Process mapping can be an excellent way for your pharmaceutical company to improve and monitor specific processes to ensure that your operations are running smoothly and efficiently.  Because the day to day work of businesses, specifically pharmaceutical companies, usually involve a multitude of different processes, mapping them out in specific charts and graphs can help to make the work look more visible and increase understanding among employees.  It also helps employees who are working on specific tasks and helps them to get a clearer understanding of what the rest of the company is doing.

Process mapping is a process that basically outlines the different steps it takes to reach a predetermined goal, which can be anything from more product efficiency to customer satisfaction.  Process mapping is usually done by outside pharmaceutical consultants who specialize in mock FDA training and process mapping, along with many other services.  A process map can accurately highlight the areas where your company needs improvement, as well as increase efficiency and improve the systems necessary for developing the solutions needed for problems.  Here are some tips to help you understand the mapping process better, and some advice to make the process easier for both parties.

The most important thing your company can do is to choose the right pharmaceutical consultant to help you with the mapping process.  You should thoroughly check out the company’s credentials and experience, and make sure they understand every process involved.  You will want to be certain to establish basic guidelines for the mapping process and make sure this is understood by both parties.  You will also want to establish a clear goal that you’re looking to achieve, so that from the outset you will have the direction and motivation to succeed.  You will also want to create a separate team on hand, which may assist in the mapping process, and offer support and expertise to the consultants running the tests.

Once the testing starts you will want them to create a rough draft of the process first, before completion of the final copy when all data has been collected and specifically arranged.  It is important to respect everyone’s opinions and contributions along the process, regardless if you agree with them or not.  You will also want to have someone record the details as you go along, and if possible a smart board or projector hooked up so that everyone can see the progress as you go.  But the most important step is to be patient.  Process mapping is not a short endeavor, and a good process map takes time to be put together properly.  But when it is completed, you will find it to be a very valuable addition to your business, and definitely worth the time and effort it took.

If you enjoyed this article, please feel free to post it to your site or blog and forward this link to your friends. Have a great day!

Don’t Forget to Subscribe by RSS or Email:

While many pharmaceutical drug companies are getting ready for their Risk Evaluation and Mitigation Strategy tests (REMS), mandated by the FDA, most companies are finding themselves very much unprepared.  Because of better evolving and ever more complex compounds being used by drug manufactures today, it is no surprise that a better kind of evaluation process is needed for thoroughly testing these drugs.  And that is why the FDA came up with REMS testing.  If your pharmaceutical company is unsure about all of the components of the REMS program or is unsure whether your company is adequately prepared, it would be a good idea to contact a life sciences consulting for more expertise.

The REMS program has emerged as a key testing program to ensure better safety in the pharmaceutical manufacturing industry.  In the past the FDA has been considered too lenient in the product approval process for most drug companies, but this is no longer the case.  The REMS testing program ensures that optimum quality for all drugs released or they will not go into post production.  Most REMS programs use web-based technology, augmented by printed materials and a very informative call center staff that can help you with any problems you might be having.  These new systems allow the FDA to amass incredible amounts of information from which FDA reports are generated, tracking product usage rates, as well as educating participants and giving them timely reminder notices.

If you are confused on what to expect from your REMS testing it would be smart to hire an outside pharmaceutical consulting firm who specializes in preparing companies for REMS testing, as well as mock FDA audits, or Pre-PAI audits as well.  REMS are short for 60-90 minute focused training modules conducted in person or even via web-conferencing.  REMS pre-testing offers you the flexibility to update your knowledge and specifically create your learning experiences based around your pharmaceutical company’s needs, as well as your budget constraints.

REMS testing forces manufactures to work closely with physicians, distributors, even consumers in a more detailed and complete way.  Preparing for this test will help your company take a better look at itself in a more scientific way, and a closer look at how your products are being used, and in what way.  It also provides an avenue for drug companies to have a more clinically based conversation with consumers and pharmacists about what is in the drugs they use, and how to properly administer them.  REMS testing is a great quality control system administered by the FDA, and it looks like it is here to stay.

If you enjoyed this article, please feel free to post it to your site or blog and forward this link to your friends. Have a great day!

Don’t Forget to Subscribe by RSS or Email:

There are a number of trends taking place lately in the pharmaceutical industry, one of them being generic drugs, the other being globalization of generic medicine.  As generic medicine is taken root in smaller, less developed countries, the big pharmaceutical companies are clamoring for a piece of the action.  With generic medicine on the rise in the U.S. and abroad, some big pharmaceutical companies have turned to underhanded practices to get these cheaper drugs out of the market.  Big pharmaceutical companies are now paying off smaller generic drug makers to halt production altogether, to keep these cheaper drugs out of the market.  But who pays the price for this in the end?

In recent years larger brand name pharmaceutical companies have started the practice of entering into agreements with smaller generic drug companies, to slow down production of their generic drugs, or halt production altogether.  Up until recently, big pharmaceutical companies have tried to work hand in hand with smaller generic drug companies over licensing rights to drugs and even making generic brand named medicine.  Even though this seems like an effective strategy, some of the more underhanded dealings by the big pharmaceutical companies may not be good for everyone.

The cost of the average generic drug can be anywhere from 60% to 80% of the brand name alternative.  But it’s not just the individuals that are hurting from these underhanded practices.  Lower drug prices also benefit businesses as well as many employers pay for their workers’ health care, including any prescription medicine they may need.  When these big pharmaceutical companies take away this option to buy generic medicine, this puts the burden directly on the consumers and the employers who provide health care for their employees.  Because brand name medicine can be so expensive this is resulting in thousands of businesses dropping health care plans for their employees altogether, putting a huge financial burden back onto consumers, often resulting in them not being able to afford any kind of medicine altogether.

Because of these recent practices by the large branded drug companies to keep any competition out, many other recipients who are not involved are being affected as well.  Many pharmaceutical sales consulting firms, who work hard to keep an eye on these recent developments, have noticed something even more alarming.  They are noticing that as many large branded companies take away the option of buying generic medicine, taxpayers are footing most of the bill.  Because many individuals have no way of affording these expensive brand named medicines many people are turning to their governments for assistance.  As the governments of the world are taking on more and more people to cover their health insurance plans, the cost is going back to the taxpayer.  In the end nobody wins but the large pharmaceutical company.

If you enjoyed this article, please feel free to post it to your site or blog and forward this link to your friends. Have a great day!

Don’t Forget to Subscribe by RSS or Email:

Because of the recent Swine Flu virus that has swept the globe, many drug manufacturers are doing whatever they can to produce ample amounts of the vaccine for this upcoming flu season, but they are having more problems than anticipated.  Many pharmaceutical companies are having trouble growing enough of the swine flu virus to produce adequate amounts of the vaccine.  Many drug companies are falling behind of this race to produce enough vaccines for this upcoming pandemic season, and it could hurt the drug companies in the long run.  Many drug companies are already going outside of the box hiring outside life sciences consulting firms to help maximize their production levels to be able to fill this massive demand for swine flu vaccines.

The FDA is currently reporting that the major drug companies are only getting to about 30% of the production rate needed to supply all the demand for this upcoming flu season.  Because of this problem reproducing the virus effectively, many countries around the world are concerned they won’t have enough stock piled vaccines in preparation for a worse case scenario.  But not all drug manufacturers are falling behind schedule.  Companies like MedImmune are actually developing excess amounts due to its innovative vaccine design process.

MedImmune is able to make so many vaccines because they are making their product from a weakened flu virus rather than a neutralized live virus.  Live viruses produce a stronger immune response then weakened viruses, but MedImmune claims it will be just as effective.  MedImmune even claims it will be more effective due to its delivery mechanism, coming in the form of a flu spray, with only one dose being adequate, rather than two doses from a more conventional vaccine dosage.

But not everyone is convinced that it will be as effective as MedImmune claims.  Some critics are claiming it will not be as effective as the standard swine flu vaccine due to its manufacturing process.  Others are claiming that they are just trying to take short cuts to fill demand to get more government contracts.  However, this technology that MedImmune is using does have its drawbacks.  Because of the spray delivery mechanism, many spray suppliers are not able to keep up with the demand for the vaccine and are only able to produce, at the most, 40 million doses.  This is well short of the needed amount, as the U.S. alone has ordered 195 million doses of vaccines from five major drug developers.  Only time will tell if the rest of the drug companies will be able to catch up to MedImmune, and if we will have the shortage of vaccines that is being predicted, but as of right now, MedImmune is the only drug manufacturer who is currently not behind schedule.

If you enjoyed this article, please feel free to post it to your site or blog and forward this link to your friends. Have a great day!

Don’t Forget to Subscribe by RSS or Email:

Many arguments have been made both for and against pharmaceutical outsourcing in the pursuit of achieving some sort of competitive advantage.  By allowing outside firms to concentrate on specific tasks, many pharmaceutical firms feel they can increase not only their performance, but deliver a better product in the end.  Too much outsourcing may have some negative effects as well.  Too much outsourcing may reduce organizational innovation within the company; it may shift certain knowledge to supplier organizations which may reduce the overall activity of the larger company.  However, pharmaceutical companies for years have worked hand in hand with a pharmaceutical consultant to develop a safer and more effective product.

Pharmaceutical companies all over the world are increasingly turning to outsourcing in an attempt to increase their overall productivity and competitiveness.  Large pharmaceutical firms are turning to smaller more specific firms to help them break through to the next level of improvement and innovation.  In order to meet the ever evolving market demands of the 21st century large pharmaceutical companies are being forced to improve the way they operate, based on innovation and efficiency.  Outsourcing for these large companies can have many advantages, but there are many barriers in the process.

One of these barriers to the global conflagration of outsourcing efficiency is that most outsourcing services are very specific to only one or two jobs.  Usually these smaller companies have very limited capabilities which means the larger companies have to look to more and more outsourcing firms to fulfill their outsourcing needs.  This makes the manufacturing process even more confusing not to mention costly.  Because of this fragmented market it can be difficult for larger pharmaceutical companies to achieve the kind of maximum efficiency they’re looking for.  That is why many pharmaceutical companies have turned to pharmaceutical consulting firms who can advise the best plans for the company to achieve the most innovation and efficiency possible.

Pharmaceutical consulting firms are designed to advise companies on every aspect of their business, to help them be more successful and reach maximum profitability.  A pharmaceutical consulting firm can give your pharmaceutical business a plan on how to achieve outsourcing efficiency, as well as fill you in on process innovation tips you may not be aware of.  They can also help your business with licensing, business development, brand management, as well as product distribution and process efficiency training.  They can look into your business and see what you can do to make your product better, safer and your business more efficient.  Before looking to outsource a vital part of your pharmaceutical company, discuss the plan first with a pharmaceutical consulting firm whose job it is to make sure that you will make the best decision for your company, not to mention your consumers as well.

If you enjoyed this article, please feel free to post it to your site or blog and forward this link to your friends. Have a great day!

Don’t Forget to Subscribe by RSS or Email:

Emerging third world markets to big drug companies has come to be the same as California gold was to miners in the 1800’s.  Every major drug company is clamoring to get their stake in these emerging markets, and is stopping at nothing to do it.  But just as many of the biggest drug making companies in the world have their sights clearly set on these emerging markets, many of these countries are turning to generic drugs instead.  This has always been the trend in less developed areas of the world, but analysts expect as the middle classes in most of these developing nations grow, there will be more of a demand for branded medicines, that may be more expensive, but are seen as having better quality.

That is why it is no surprise that the acquisition of generic drug companies, by larger branded drug corporations, is on the rise.  As these larger drug companies are scrambling to buy the rights to generic drugs they can sell from their own, better trusted brand, companies like Wal-Mart and Kroger are clamoring to get a piece of the action.  These companies know if they can buy generic drugs from these emerging markets at bottomed out prices, they can sell them in their retail outlets for a large profit.  Cheap copycat generic drugs are becoming a necessity to some of these retail pharmaceutical companies because their losing more and more money everyday to well established drug companies, while at the same time having these cheap drugs attracts more customers to their stores.

But according to many in the pharmaceutical sales consulting industry, this may be a dangerous trend.  Because companies like Wal-Mart and Kroger are most likely buying their generic drugs from poorer countries like India and Indonesia, this is causing a big concern about the quality of the drugs.  The FDA is trying to crack down on the rising sales of generics from emerging markets to the U.S and other European countries, but the truth is, there’s really not much they can do about it.  As the need for cheaper, more available drugs continues to rise, there will be no choice but to turn to generic drugs on a massive scale.

But the large drug companies have not thrown in the towel just yet.  With the emergence of generic drugs in these emerging markets, drug companies have started to turn more to generic branded medicine of their own.  They have decided to buy the rights of much of this generic medicine themselves, so they can put their brand on it, giving it more legitimacy in markets around the world.  With all that being said, there’s one thing we do know, that this is only the beginning of a colossal struggle between the smaller generic drug companies and the large branded drug corporations.

If you enjoyed this article, please feel free to post it to your site or blog and forward this link to your friends. Have a great day!

Don’t Forget to Subscribe by RSS or Email:

The healthcare and pharmaceutical market research company Manhattan Research, has established that three out of four nurses recommend health websites to the patients they tend to.  The study focused on the nurses’ preferred technologies, how they are implementing them now, and how they plan to continue utilizing them in the future.  This study was conducted online among a sample of 1001 U.S. nurses and physician assistants.

It was discovered that nurses are very knowledgeable about health technology.  Normally, and just the same as a doctor, a nurse spends around eight hours a week surfing the Internet for professional reasons.  Most of this time is in between patient consultations.  Also, nurses proved to be very active and interested in learning about medical product information online; more than eighty percent have clicked on biotech, pharma or device companies’ websites during the last year, especially Merck, AstraZeneca, Pfizer, Sanofi-Aventis and Eli Lilly.

Even though marketing departments and pharmaceutical consultancy firms are aware of the importance of nurses in patients’ health care choices, it has been hard to pinpoint an effective way of taking advantage of this situation, until now.  Manhattan Research’s study clearly presents the big opportunity the Internet is.  It is a key element to influence and connect with nurses, and thus, reach patients directly and effectively.

Among the topics analyzed in the study are:

-    Technology and Internet use for professional purposes, including email, websites visited, search engines used, wikis, social networking sites, HCP online communities, newsletters, blogs and podcasts
-    Channel mix, what sources are preferred for professional information and the use or interest in pharmaceutical website features
-    Email use and opportunity, how they communicate with patients
-    Patient interaction and education, the source of patient education materials, the recommended websites and influence on treatment decisions
-    Handheld devices, the frequency, professional functions, clinical references and preferred points of access
-    Practice technology, electronic prescribing, EMR use and activities
-    Continuing education, current and future way to do it (online, mobile, traditional), websites used
-    Practice profile, work setting, number of patients seen and number of prescriptions written

This is a study worth reading.  For more information on the results, visit www.manhattanresearch.com.

If you enjoyed this article, please feel free to post it to your site or blog and forward this link to your friends. Have a great day!

Don’t Forget to Subscribe by RSS or Email:

Pharmaceutical process development covers a wide spectrum of testing and procedures all built in to make sure that your pharmaceutical company is running at maximum efficiency.  Many pharmaceutical manufacturers seek outside help from pharmaceutical consulting companies to help their business produce maximum efficiency, produce the products economically, and produce the product up to the proper codes and regulations.  Pharmaceutical consulting firms can also help with the production, finance, distribution, marketing, and program management of each product, or firm, to supply an area of expertise that would be hard to achieve on one’s own.

Some of a pharmaceutical consulting firm’s main services are process development, validation, and stability testing programs, just to name a few.  What they can do is provide assistance to your pharmaceutical company to help reduce your costs, the cost of production, cost of distribution, and so on, making sure your company is running at optimum efficiency.  They can ensure that optimum productivity is being achieved by helping you to discover red flags and errors in your process development, which could save thousands in time and money.

Pharmaceutical consultants will give you clear, adaptable instructions that you can quickly apply to your business immediately.  By using the right strategies, and innovative approaches, a pharmaceutical consulting firm can offer you pharmaceutical expertise in their approaches to product development, research and operations management.  They can help to speed up the delivery of safe and effective therapeutics, increase product quality, and maximize the returns for your business and its shareholders.  Why spend thousands of dollars, not to mention waste thousands of hours of productivity, because your process development is off?  No business in the world can afford to do that.  That’s just a bad business decision.

Pharmaceutical consulting companies can also help to fill you in on new technological innovations, which can help to improve your product, or improve your production capacity.  By ensuring that you are up to date with all the latest technological systems, and innovations, you will be able to take better steps at maximizing your product efficiency.  Process development testing covers a wide range of services from clinical support evaluation, to helping form business plans, to process mapping, competitive analysis, and so on.  They will deliver a clear outlook, of what your company is doing wrong, as well as what it is doing right to ensure that your pharmaceutical company is doing everything that it can to be successful.

If you enjoyed this article, please feel free to post it to your site or blog and forward this link to your friends. Have a great day!

Don’t Forget to Subscribe by RSS or Email:

Having a mock PAI audit for your bio-pharmaceutical company can be a very important process if you are looking to achieve the highest quality.  The mock audit will ensure that the process, system, material, method, product, equipment, and personnel, all meet the intended purposes and function, allowing for a reliable and safe production.  However, having mock audits done by your own company can sometimes be a conflict of interest, as usually an outside firm would be more objective and thorough.  When preparing for your PAI audit it is an excellent idea to hire an outside pharmaceutical consultant company to assist with your mock auditing efforts.

The auditor’s job in a mock PAI audit is pretty straightforward.  Their job is to verify if the company’s policies and procedures are being followed, assess the site’s GMP practices, verify that the required systems and controls are in place, and that the factory is meeting all FDA regulations.  Also, during the audit process physical and chemical performance characteristics should be clearly identified and translated into the correct specifications, including acceptable ranges, etc.  The validity of these specifications is verified through the proper testing and challenge during the development and initial production.

Some of the auditor’s more specific functions may be more complex.  They will investigate the area thoroughly to verify if company policies and procedures are being strictly followed.  They will do this by determining whether all production activities and systems comply with all FDA regulations, not to mention any other regulatory agencies or site requirements.  They will also identify the depth of the identified problem areas, as well as what steps can be done to fix these areas.  The mock auditor will also provide management with the necessary information regarding levels of compliance for the site and its suppliers.

Having a PAI mock audit may not always be the most exciting idea, but the long term benefits of having one of these audits are without question.  By identifying problems early in the production process, you can not only save your business money, but also time and resources as well.  It will also bolster your image to the FDA, and you will know you are ready for any surprise inspection in the future.  It will improve your image to your customer base, and you will receive far fewer product complaints in the future.  By ensuring that your company is running at maximum efficiency, and maximum safety, you are ensuring that your business will have what it takes to be successful in the long haul.

If you enjoyed this article, please feel free to post it to your site or blog and forward this link to your friends. Have a great day!

Don’t Forget to Subscribe by RSS or Email:

Doctors, lawyers, pharmaceutical companies, life sciences consulting firms, and health care providers are all keeping a very close eye on the development of government regulations of DTC genetic testing.

As of this post, federal regulations differ from state to state with each having its own full or partial regulations or complete restrictions. Only 12 States allow direct to consumer testing, 13 have complete restrictions in place and 24 have partial limitations to what they will allow.  At the present time, both New York and California have complete restrictions against direct to consumer genetic testing, and the companies that want to provide these services are wondering if other states will follow their lead.  Many of these companies are locating in the U.S. because of these loose regulations.  Countries like the U.K. are not as attractive to this business as strict regulations are already in place.

But many consumers are keeping a close watch on these developments too.  There are definitely three factions in the game, those who want it, those who don’t and those who agree that partial restrictions are okay.

Advocates of DTC genetic testing feel that it helps consumers take a proactive approach to their own healthcare.   Many believe that testing for diseases such as cardiovascular disease, or cholesterol problems would encourage people to seek professional help sooner than they normally would, and in most cases before symptoms even occur.  They are also in support of genealogical testing that can alert individuals to health concerns that may be inherited.

For those against DTC testing, the issues are more moral and ethical. Their concern centers on the many emotional, social and even financial factors that could be overlooked without the guidance of a health care professional.  Other moral concerns might be that the day would come, for example, when health insurance companies demand genetic testing before approving policies, or employers demand it before hiring for positions.

Those who support partial regulation can see both the good and the bad.  Some of the simpler testing could perhaps be left in the hands of the consumer.  The more complicated tests, and those with greater impact on the lives of the consumer, should be administered with both the psychological and medical guidance of the appropriate health care professional.

There are also those who fear that a lack of federal regulation would allow genetic testing companies to take advantage of those somewhat desperate consumers and advertise falsely needed services or charge exorbitant fees.

And then, of course there is the argument that without interpretation of test results by competent professionals, consumers could make poor decisions regarding their present and future health care.

It is, to say the least, a most complex issue, and one that is undergoing very close scrutiny by everyone.

If you enjoyed this article, please feel free to post it to your site or blog and forward this link to your friends. Have a great day!

Don’t Forget to Subscribe by RSS or Email: