Work can be a stressful place, and in the right kind of stressful environment, it can almost be unbearable, especially if you have a monotonous, sometimes tedious job, where you perform the same repetitive functions over and over.  These kinds of jobs like assembly line work, laboratory managers, or production supervisor positions, just to name a few, can create such anxiety for employees that they might feel there is no escape.  However, there are a number of exercises and other techniques you can do at work, to feel less stressed and more productive, as well as happier in the workplace.

Stress can be a devastating mechanism if left too long unchecked.  However stress can sometimes be a good thing.  It can motivate us and help to make us more prepared, more focused.  However, too much stress can be devastating to the body, as well as make us irritable, irrational, and can literally kill us if left unchecked for too long.  But taking a different approach to stress, and trying different techniques at work to deal with stress, can make all the difference in your physical and mental health.  Larger companies all over the world, as well as companies in the Fortune 500 and pharmaceutical industry often recommend workshops and seminars for their employees to reduce stress levels at work.  There are even consulting firms, like life sciences consulting firms for example, who can actually teach companies what to do to create a less stressful work environment.

One of these techniques is to improve your organization and time management skills.  This means to make your workplace as tidy and organized as you possibly can.  Too much clutter on your desk, or in your office, only increases stress levels, and leads to less productivity.  Create a system so you can keep your workplace organized, and it will pay dividends down the road.  Also learn how to take deep breaths throughout the day.  By just taking deep controlled breaths for simply 5 minutes before, during, or even after work, when feeling overwhelmed or stressed, can have a profound impact on your state of mental health, as well as reduce stress.  By practicing these deep, slow breaths at work, you can replenish your body’s oxygen supply, which will lead to more energy and better state of calm and mental preparedness.

It is also a good idea to take more small breaks at during the day.  By taking a 5 minute break at different intervals throughout the day, can work to break up the monotony of work and reduce stress levels.  You can go for a short walk outside, or just get away from your office for awhile, anything you can do to get your mind, and your body, doing something other than work.  There are also small things you can do to improve your stress levels at work.  You could get more sleep, surround yourself with more positive people, or even just learn to listen better.  Oftentimes you may feel stressed at work because you don’t understand your assignments clearly, but if you learn to listen better, and more thoroughly, you will be able to drastically reduce the confusion that leads to stress.  Stress can be a killer, but if you learn to deal with it properly, it can be one of your greatest strengths.

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With the health care debate raging in the United States, many experts have already forecasted many possible scenarios for what could be the end result, but are they accurate? As lawmakers continue to wrestle over such issues as the public option, and extending coverage to the uninsured, there is no debate that the government is looking to cut costs in the health care system, which could spell trouble for the pharmaceutical industry.  The pharmaceutical industry knows that with health-care reform on the way, the prescription drugs industry will be the first to get the axe, losing major pricing power, especially in the Medicare market.  While it is still up in the air whether a public option will pass, the pharmaceutical industry knows that a strong government controlled pricing plan spells big problems for the industry.

Even though the pharmaceutical industry has reason to be concerned, according to some pharmaceutical sales consultants all over the country, health care reform is not all bad news.  Because of the 46 million uninsured U.S. citizens likely to get some form of health care in the next 5 years, that equates for big profits for the pharmaceutical industry.  With more insured Americans getting more access for branded and generic prescription drugs, this will only mean more business for drug makers and a boost in demand.  But the pharmaceutical industry is not so convinced.  Because half of large drug company sales come from overseas, they see this boost as being inconsequential to the money they are going to lose on the federal price gauging that is likely to take place.

Here are some possible health care scenarios, some which may be good for the pharmaceutical industry, some which could even be disastrous.  One scenario is that the government will use its buying power, through Medicare programs, to demand lower drug prices from the pharmaceutical industry.  This program could lower the drug prices in Medicare up to 15%, with the burden of cost falling directly on the pharmaceutical companies.  However, with Medicare only representing about 20% of drug spending in the United States, and roughly half that world-wide, it would only amount to about a 2% decrease in the cost of pharmaceutical drugs.  However, this is not the only scenario.  Some expect that with the increase in coverage from formally uninsured citizens, the government will demand Medicaid pricing for this group, possibly slashing prices of U.S. drugs up to 10%.

Even though the pharmaceutical companies support health care reform, they may not be eagerly supporting a nationalized health care plan.  A nationalized plan, although unlikely at this point, could cut prescription drugs up to 15% even to 30% if the national plan offers very little choice for consumers.  Under this worst case scenario for the pharmaceutical industry, they could see their stock values fall up to 40%.  Any pharmaceutical consultant will tell you this scenario is unlikely, but it is speculations like these that fuel the passion and uncertainty that has become the health care reform debate.  Only time well tell.

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Recently, an international team of researchers based in Texas and Japan, have been experimenting with an obesity treatment nicknamed “Fatostatin”, that has been shown to not only make mice lose weight, but also shows great promise in the treatment of diabetes, and even the lowering of cholesterol.  These scientists have identified a small molecule therapy program that alters the genetic code involved in the way the human body turns food into fat.  Because it has been proven to be effective in dramatic weight loss, and in lowering cholesterol levels, it has been considered to be an efficient treatment in the struggle to treat diabetes.

This Fatostatin drug works to block increases in body weight, fat accumulation, and blood glucose, even with unconstrained food intake.  It is important to note that the only successful tests done so far have only taken place with the use of animal subjects, but the scientists are very optimistic.  They believe this new, experimental drug could have a huge impact, not only in weight loss, but in controlling cholesterol levels, blood glucose levels, and insulin levels in the body, which could be used to treat diabetes.  The scientists believe it goes back to the origin of fat synthesis, where scientists believe they have actually found a way for the body to stop gaining weight.  But is this even possible?

This new Fatostatin drug works by interfering with element binding proteins that influence a group of genes that are triggered during excessive food consumption.  It works by essentially, switching off the body’s negative reaction to food, by turning food directly into energy, or waste, and not stored fat.  After one month of treatment, the mice used in this study have seen a 12% reduction in their body fat levels, as well as a staggering 70% drop in their blood sugar levels.  As promising as this may seem, many obesity drugs, even with prior success on animal test patients, have had little success in humans.  But according to some high ranking pharmaceutical consultants, this drug could be the way of the future for not only fighting obesity, but curing complications to obesity like cholesterol, heart disease and diabetes.

According to some in the bio-tech industry, as well as prominent pharmaceutical consultants, further testing is needed to really find out if Fatostatin is the new miracle drug of the future, or if it’s just a flash in the pan.  But as new technology surfaces in the ever evolving Bio-Tech industry, molecular breakthroughs like this could be commonplace.  As for now, scientists are very excited about Fatostatin and are looking to test it out on humans soon.

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Would your pharmaceutical company know what to do if the FDA suddenly showed up at your door?  Would your senior management be ready, would your staging room be ready?  Would your receptionist be ready to handle the protocol that takes place during an FDA audit?   Does your pharmaceutical company have the correct documents in place needed for an FDA audit?  An FDA citation can set your company back months, even years, not to mention the thousands of dollars in fines your company is likely to face.  If you’re not sure that your company is FDA compliant, it would be an excellent idea to hire an outside pharmaceutical consulting firm that specializes in mock FDA audits and regulatory inspection readiness.

This outside pharmaceutical consulting firm will help you understand why you might be getting audited, and prepare your company to pass any surprise or scheduled regulatory inspections, that might be in your company’s near future.  They will help you understand the purpose for the inspection, and help you make ready all the necessary regulatory filing that may be involved.  They will inspect all the logistics in and around your company and will work to prepare your site according to FDA standards.  They will help to prepare your computer and automated systems so that they will be compliant for any regulatory review.

Another important pre-testing measure that an outside pharmaceutical consulting firm can offer is a quality systems gap assessment.  These tests are vital for any inspection training that your company is looking for to prepare for your FDA audit.  They will test all procedures and analytical methods to see that they are up to par and can be validated.  This includes methods for testing, sampling, and data evaluation.  They will make sure that all your equipment used for testing and sampling is properly calibrated, and well maintained.  Environmental conditions such as humidity, oxygen, temperature, even electromagnetic interference will all be monitored and controlled.  They will also work to make sure you have the specific documents in place, such as policies and a specific quality plan.

A pharmaceutical consultancy firm will help provide your company with the tools and expertise needed to prepare your organization for any regulatory inspection, surprise or mandated.  They will utilize the inspection results to give your company a competitive advantage, while teaching your company how to stay ready long after the initial mock testing is completed.  Creating an accurate and thorough system is key to develop an effective regulatory training system, which will help your pharmaceutical company to pass any FDA inspection every time.

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It is a well understood fact that such repetitive jobs like laboratory testing, and other assembly line type of work, may cause an overwhelming sense of stress and anxiety, as the workers deal with such levels of repetition.  It is not uncommon to feel claustrophobic, extreme anxiety, as well as high levels of stress, as you learn to cope with the monotony that is repetitive work.  Although you may feel like this anxiety and stress are just a part of the job, there are things you can do to reduce this stress, and create a better mental state of health at your work environment.  One of these steps is doing simple meditation exercises while at the workplace.

Meditation in the workplace is actually not a new concept, and has been incorporated into the workplace since the early 1960’s.  However, as the mental health of workers starts to come more into play, as the corporate culture intensifies, performance enhancing techniques, such as meditation, is starting to gain wider acceptance.  As a more enlightened management style begins to take shape in larger Fortune 500 companies, as well as smaller firms all over the world, the need to replace ineffective patterns of working, as well as improve employee mental health, is at the forefront of many workplace initiatives.  And this is no truer today than in the pharmaceutical industry, where monotonous, but highly specialized laboratory work, can lead to disaster if the laboratory workers are not as sharp, and mentally focused as they can be.  This is where meditation comes into play.

With meditation training in the workplace, employees no longer need to feel the anxiety of being imprisoned at work, or the claustrophobia that is associated with monotonous work.  The ability to train your mind to stay calm, under any circumstance, is at the forefront of what meditation is about, and how it can be used in a practical way to raise awareness as well as a heightened sense of calm at the workplace.  Just practicing deep breathing exercises for 5 minutes before every shift, can have a tremendous impact on your employees state of calm and mental health throughout the day.  Studies have shown that individuals who take time to meditate before, or during work, sustain higher levels of productivity, as well as more happiness and job satisfaction.

Many pharmaceutical companies, as well as pharmaceutical consulting firms, are recognizing the profound benefits of meditation in the workplace, and advise that other companies start to look into it as well.  They have found that individuals who are encouraged to meditate at work, experience a greater sense of calm, not to mention a greater willingness to contribute as well as communicate with other workers.  They have higher job satisfaction, and are more likely to be more productive.  These benefits are not only good for the average employee, who might incorporate meditation into their professional lives, but it is smart for the company as well.  The benefits from practiced meditation can mean better productivity, which means a better return on your investment, better mental health for employees, which means lower health care costs, as well as an overall sense of happiness and purpose at the workplace.

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The U.S. has fallen behind Europe when it comes to drug research and development. A new study shows that European pharmaceutical companies outrank their U.S. counterparts when it comes to biotech, first-in-class and orphan products.

Pharmaceutical consultants state that this evidence is a blow to the United States. While President Obama tackles the controversial health care reform debate, this study raises further awareness of the high cost of out-of-pocket medication expenses for U.S. consumers.

European research and development isn’t nearly as costly compared to the high cost of patent-protected drugs in the U.S. – this is where the U.S. falls short. The study examined new chemical entities (NCEs) from 1982 through 2003. These drugs (NCEs) are introduced to the world’s largest markets. The study focused on the percentage of drug research funds to the percentage of NCEs credited to the U.S., Europe and Japan.  Each area of research was measured for productivity.

The study found that the U.S research funding increased between 1990 and 2000; however, its research relativity remained at only .75. As a result, pharmaceutical companies in the U.S discovered fewer drugs (compared to their R&D spending). However, Europe launched more new treatments to the market than expected (as compared to the proportion of their R&D spending)

Another key component of the study showed that evidence doesn’t support that most new drugs are high quality or even beneficial/important to patients using these drugs. Many drugs on the U.S market, such as new cancer-related drugs, bring in large profits at high costs. The biggest issue is that these drugs have not been clinically proven as better than existing cancer drugs.

U.S. pharmaceutical companies may develop more drugs but they aren’t necessarily offering exceptional quality drugs to patients. These high prices allow the companies to spend 2.5 more on marketing these drugs, compared to spending money on into research and development. Unfortunately, the U.S. drug development system holds more value over sales and marketing compared to the discovery and therapeutic value of drug development.

Europe is also far advanced compared to the U.S. when it comes to biotech. European researchers have played integral roles in the development of proteomics and sequencing genomes. Compared to their U.S. counterparts, European biotech companies are making huge impacts in global markets when it comes to drug discoveries.

Even European firms specializing in basic technology such as chemical libraries and throughput screening are thriving, and use more advanced business models compared to the U.S.  Companies in the Netherlands and Sweden combine both advanced scientific technology and academic knowledge when it comes to R&D.

The study concludes that the United States is lagging far behind in pharmaceutical innovation. As the U.S continues to tackle with its health care reform issues and the rising costs of drugs, they need to take a lesson from European science.

Biotech, research and drug discovery are at the forefront in Europe. Pharmaceutical consultancy firms believe the U.S. needs to jump on board when it comes to new research tools, diagnostics and therapeutics, or they will continue to fall behind Europe and the rest of the world.

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Pharmaceutical and biotech companies are turning to the future of personalized medicine – the personalized treatment and diagnosis of disease. In the past, a “one size fits all” approach to medicine hasn’t been the best solution. Scientific research didn’t take into account the influence of genes on an individual’s health and well-being. Personalized medicine has the potential to vastly improve the way healthcare issues are managed, especially concerning the diagnosis and treatment of disease.

Pharmaceutical consultants state that personalized medicine offers three main benefits:
•    Improved diagnosis and early detection of disease

•    Efficient drug development

•    Accurate, cost-effective therapies

Pharmaceutical and biotech companies play significant roles in personalized medicine (or pharmacogenomics).  Pharmacogenomics is the study of how a person reacts to medication based on their individual genetic background.

Personalized medicine is a collaborative effort amongst government and international agencies such as the FDA (Federal Drug Administration) and NIH (National Institute of Health). Drug and genetic test manufacturers and health care providers also need to work together to implement tests and therapies.

One of the biggest leaders fighting the personalized medicine cause is SAEC (Serious Adverse Events Consortium). Along with the FDA, SAEC unites government agencies, academic institutions and pharmaceutical companies. Their mission is to validate DNA-variants (which is useful in predicting risks associated with drug-related adverse events). Their collective research focuses on the impact that genes have on people’s response to medication.

Pharmacogenomics paves the way for the development of life-saving drugs. By determining biomarkers, pharmaceutical and biotech companies identify new disease subgroups and design drugs to target these new subgroups.  This personalized medicine approach includes genetic screening programs which properly diagnose specific diseases.

This screening process is also vital for doctors when choosing proper medication/dosage for patients. Doctors and patients work together to better treat and manage disease. Some patients may experience adverse reactions to medication due to their genetic variation (which could cause serious side effects). However, a patient with a different variation may not experience any side effects.

Personalized medicine analyzes natural variations in people – their dietary/lifestyle habits, environmental factors, stress levels and their DNA make-up. These factors play vital roles in analyzing people’s health, and determining if they are more susceptible to disease. For example, natural variations in genes make certain people pre-disposed to certain types of cancer.

Molecular analysis also determines which medication works best to treat early stages of certain cancers (such as breast and colon cancers).  For patients who are predisposed to these cancers, doctors can assist patients with lifestyle/health changes to reduce their cancer risk.

Pharmaceutical and biotech companies spend years and billions of dollars on R&D before drugs hit the market. Pharmacogenomics not only saves these companies money, but they help these companies better focus on their R&D.

If these companies know a person has a genetic variation towards a drug that gives them an adverse reaction, they are excluded from clinical trials. This not only targets patients who can be really helped by the drug, but it also speeds up the clinical trial process.  Any pharmaceutical consultant will agree that, as a result, the pharmaceutical industry plays an integral role in the future of personalized medicine.

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Oftentimes, one of the hardest tasks for a pharmaceutical or life sciences firm to achieve is not necessarily starting a successful business, but maintaining a successful business.  This is mainly because the life sciences market is extremely competitive, and so much depends on the efficient use of resources, as well as staying current with the newest technologies and methods of production. For a smaller pharmaceutical company, this task can be even more daunting, as budget and staff constraints are often limited, affecting everything from timing, to regulation compliance.

Fortunately, for smaller pharmaceutical companies, the appearance of more and more life sciences consulting firms has made it possible for smaller firms to improve their competitive advantages, as well as give larger companies clearer strategies to follow for success.  These firms can help your business to not only stay competitive, and stay in the market, but also give your company its best chance to succeed and grow.

Each life sciences consulting firm is different and can offer your company different services.  The first step is to clearly determine what you feel your company’s needs are, and where your company needs improvement and expertise.  Through this assessment you will be able to determine what consulting services your company needs, and form a basis from which to work from.  There are a number of consulting services your company may not even be aware of which can drastically improve your business.  Here are a few examples of what a life sciences consulting firm can do for your business.

A life sciences consulting firm can save your company time and money by helping to speed up the rate it takes to conduct clinical trials, monitoring, research, as well as any other application process.  They can also provide you with a specialized staff that may have expertise in areas in which your company is lacking.  They can also find experts in almost any field of biotechnology, to share their knowledge and experience with your company.  Most importantly, they can teach the staff you already have in place, to do things better, faster, and more efficiently, not to mention, familiarize your company with the newest methods and technologies, to help you keep a competitive advantage.

A top-notch life sciences consulting firm will help give your pharmaceutical company the flexibility it needs to adapt to current trends and changes taking place within the industry, as well as save your company time and money in the process.  They will help your company to better understand all the procedures and regulations, and give your firm clear answers to help guide you along your process development.

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As the debate rages in the United States over health care reform, some are seeing good signs for the public sector, but bad signs for the pharmaceutical industry.  Despite Republican-backed legislation that prohibits any use of comparative effectiveness, which means that the government can’t use research to dictate care, they are receiving major pushback from the pharmaceutical industry.

Comparative effectiveness is a hot bedded issue because it challenges the power of the government over the power of the public sector.  The big pharmaceutical companies have been attacking this for years, as they fear head-to-head studies would favor the lower-cost treatments over typical, more expensive branded medicine.  While the government, on the other hand, simply sees this as just another way of cutting cost.  The large pharmaceutical companies don’t want these research mandates being the final decider in treatment guidelines and insurance coverage, while the government sees this as unnecessary and wasteful spending, as well as being bad for the common citizen.  And the debate rages on.

However, the Senate is currently working on a compromise to resolve this issue, but will it be enough?  The Senate is currently working on many comparative effectiveness provisions in its new version of the health care bill, which contains some interesting elements.  The Democrats in the Senate supports either non-affiliated pharmaceutical consultancy firms, or non-profits, to conduct all the research, instead of a government appointed agency.  The bill would also negate any medical practice guidelines or insurance coverage recommendations as being the final say in recommending treatments, as the pharmaceutical companies fear.

However, the Agency for Healthcare Research and Quality, as well as the National Institute of Health beg to differ.  They see comparative effectiveness as an optimum way for not only doctors, but also patients, to have the ability to pick the most effective care, as well as control health care costs.  They are stating that without the proper research into these new expensive treatments, there will be no way to cut costs on these expensive treatments down the line, thus making them unaffordable for those who need them most.  But the large pharmaceutical companies disagree and say that any cost comparisons would only lead to further denial of care, not the dissipation of it.

As the debate rages on, speculations on who’s really looking out for the American people are starting to surface.  With the Democrats promising change in the last election, a lot of Americans are just seeing politics as usual.  A lot of people in the Democratic Party are seeing conservative Democrats, called “Blue Dog” Democrats, as being the major stumbling block to this compromise taking place.  It has also been reported that “Blue Dog” Democrats have received much more funding from the pharmaceutical industry in recent years, and are in the tank for the pharmaceutical industry.  Pharmaceutical consulting firms believe only time will tell how this story unfolds, but as cooler weather approaches, there is no doubt that this debate about health care will only heat up, rather than cool off.

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Drug/device combination products raise compliance and regulatory issues in the pharmaceutical industry. On their own, each drug and device has their own specific type of marketing and good manufacturing practices regulation. However, when drugs and devices are combined together, they pose a new compliance question – how will this new combined product be regulated as a whole? Pharmaceutical consultants point out there isn’t one easy solution.

Combination products consist of the following:  products that are combined with two or more regulated drugs, devices or biologics (i.e. drug/device, biologic/drug, or drug/device/biologic). Because of the diversity of these drug/device combinations, a one-size-fits-all approach doesn’t always work. For example, these drug/device products may consist of either drugs packaged along with devices, or the drugs coated on devices. Another combination is drugs and devices that are packaged separately. These separate drugs and devices may be produced by different manufacturers.

Another issue that arises is the complexity of drug/device combinations. Combined products could be as simple as a syringe pre-filled with drugs. They also could be as complex as chemotherapeutic drugs combined with monoclonal antibodies.

The U.S. Federal Drug Administration (FDA) has made it a top priority to address these ongoing compliance issues. They developed the Office of Combined Products (OCP) which was a result of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The OCP has taken the mystery out of the compliance process for drug/device combinations, and has proved successful.

The OCP’s main priority is to ensure that these combined products are sent to the appropriate FDA Centers. They oversee timely premarket reviews of combination products. The OCP also oversees consistent, effective post-market regulations.

However, OCP doesn’t handle the entire process associated with drug/device combination product compliance. They first determine the drug/device product’s “primary mode of action.” The OCP analyzes what is the “most important therapeutic action of a combination product.” Based on this “primary mode of action,” the OCP directs these drug/device products to the following Centers based on their analysis.  The responsibility lies on the following FDA centers: Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH).

Because of the regulatory complications associated with combination products, the FDA created an effective way to handle this problem. The OCP wrote a SOP for IntercenterConsultative/Collaborative Review Process. It outlines the necessary procedures and processes that the three Centers must follow when reviewing combination products.

The FDA also consults with applicants and assists them with marketing applications. According to the FDA, single marketing applications for combination products usually work for clearance. Dependent upon the combination product, the FDA may recommend two separate marketing applications. The FDA advises applicants to contact the OCP to discuss the appropriate marketing application based upon their drug/device combination.

Pharmaceutical consultants agree that the FDA’s OCP has made great strides over the past few years with compliance issues for drug/device products. The OCP conducts trainings for both staff and applicants throughout the year to resolve combination product issues.

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