It has been proven through an FDA-approved clinical trial that treating heart attack patients with adult stem cells is safe and seems to repair damaged heart tissue.  The results of this study, which was conducted by Joshua M. Hare, M.D. and director of the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine, and sponsored by Osiris Therapeutics of Columbia, Maryland, were published in the December 8th issue of the Journal of the American College of Cardiology.

The first phase of the trial intended to prove the safety and efficacy of injecting a formulation of adult mesenchymal stem cells, Prochymal, in patients right after they suffered a heart attack, to diminish the damage to the heart muscle.  The sample consisted of 53 patients who had suffered a heart attack between one to ten days before.  They were randomized to one of three doses of stem cells, each dose compared with placebo.  After six months, researchers analyzed the serious side effects that were related to the treatment and used echocardiography to measure the efficacy.

The study discovered that the patients treated with stem cells presented fewer side effects like cardiac arrhythmias and showed important improvements in their heart, lung, and global functions.  According to Dr. Hare, the echocardiography showed better heart function, especially in patients with lots of cardiac damage.  Up to date, damaged cardiac tissue cannot be repaired through any known scientific method, and close to a million United States’ citizens suffer heart attacks each year.

These results will put to rest some of the discussions in regards to clinical stem cell research for heart disease.  Although many think that it is too soon to test stem cells in patients, this study has proven the value of exact and controlled clinical trials. In doing so, it also establishes the basis for the development of novel cell heart therapies.

Many believe that this trial acts as a key point of reference for the advancement of these types of approaches. There are several advantages to mesenchymal stem cells as cell-based therapy; among these are:

-    Can be taken from donors that are genetically different
-    Are easy to prepare
-    Tend to gather around injured spots

It is certainly exciting to imagine what is ahead.  Each study will provide new information, new teachings, and new possibilities for the use of adult stem cell therapies to treat cardiac patients.

Contact your pharmaceutical consultancy firm for more information on stem cell research and the promising future it presents.

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The vaccine manufacturer MedImmune announced at the end of last year that the H1N1 vaccine had lost effectiveness since it first appeared.  Nevertheless, according to U.S. officials, this does not imply a safety issue.

The mentioned manufacturer withdrew thirteen lots of the vaccine against the H1N1 influenza out of its own free will because these had lost part of its effectiveness since they were first manufactured.

In response, Norman Baylor, the director of the Office of Vaccines Research and Review at the Food and Drug Administration, stated that this situation does not create a safety issue because every lot had passed the pre-release testing required to ensure safety, purity, and effectiveness.  He maintained that the loss of effectiveness was a slight one.

The thirteen lots that were withdrawn were a part of 4.7 million doses of the intranasal vaccine, whose origin is a live weakened virus; however, officials think that the majority of these were administered during October and November of 2009, when the vaccine was still performing at its maximum effectiveness.  At the moment of the announcement, the manufacturer still had in its possession 3000 doses affected by the withdrawal, but it is not clear how many are scattered around the country.

This is not the first time lots of the H1N1 vaccine have been withdrawn.  Some weeks after MedImmune’s incident, Sanofi-Aventis withdrew 800,000 doses of the vaccine for children for the same reason; their effectiveness had decreased.

Baylor accepted that this pattern is not normal, having two withdrawals of a seasonal flu vaccine in the same season; however he explained that these are biologicals created from living organisms and thus, it is normal for the vaccine to lose effectiveness over time.

It is for this reason that the vaccine has an authorized shelf life of 18 weeks and that the FDA demands that companies measure its effectiveness regularly.  MedImmune tests its products on a weekly basis, and it was on one of these occasions that the loss of effectiveness was accounted for.

Baylor noted that the withdrawal was a measure of precaution.  He added that those who received vaccines from these lots are fully protected and don’t need to get another shot.  According to him, there is no negative impact whatsoever on the vaccine’s safety and effectiveness.

Contact your pharmaceutical consulting firm, because it should have a lot to say on this respect and lots of important recommendations.

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From 2008 until 2023 there will be an improvement in vaccines, and their sale and use will experience a rebirth.  Vaccines will be one of the fastest growing areas of the pharmaceutical industry, and their profits will increase by the hundreds in percentage terms during this period.

The Global Vaccines Market, 2008-2023, is a report that describes the market trends in a qualitative and quantitative manner.  Vaccines have grown in importance in developed as well as developing countries because of the current epidemic patterns and healthcare needs.

The most important reason for the growth of vaccines is that they are extremely cost effective in fighting disease, thus, governments and private health providers will increasingly encourage their use.

There is increased awareness now in terms of  the benefits of preventive medicine relative to  the better quality of life and reduction of healthcare costs for consumers, and the vaccine industry is answering the call with new products, and making full use of the technological advances in biotechnology.  There is a lot of potential in this area, as much for therapeutics innovation as commercial return..  Currently, there are more than 1000 vaccine candidates in research and development around the world.

Therapeutic vaccines are different from the vaccines currently on the market.  These not only prevent infection, but work with the body’s immune system to fight disease and disorders, including cancer, addiction, and allergies.

The Global Vaccines Market report focuses on these aspects within the field of vaccines:

-    Sales projections for vaccines by disease area, brand and country, including new therapeutic vaccines

-    Analysis of strengths, weaknesses, opportunities, and threats in regards to the vaccine industry

-    Expert opinion from key leaders in the field

-    In-depth analysis of the vaccine pipeline

-    Analysis of the prospects for therapeutic vaccines

-    Geographical division of the vaccine market, including the leading emerging markets of China and India

-    Coverage of future trends in vaccine technology, formulation, and manufacturing

-    Identification of crucial industrial players in the vaccines market

This report gives a comprehensive analysis of the vaccines market using only primary and secondary research, and it includes full transcripts of interviews, company reports, filings, and industry databases.

This report, along with pharmaceutical consultancy, could mean the difference for the success of your business in the years to come.

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LIMS (Laboratory Information Management System) is becoming more and more crucial to ensure quality control and assurance in laboratories, because most analytical activities within a modern lab work to support the process control function, and QC is vital for that.

Currently, advances in IT and LIMS products are simplifying QA/QC through the computerization of: data entry from instrumentation, test result data specification review, assignment of lab activities and workload, and management analysis and reporting.

LIMS offers many advantages to the lab when trying to reinforce QA/QC controls such as:

-    Personnel qualification and training
-    Labeling, storage, and expiry of reagents, solutions and hazardous chemicals
-    Equipment documentation, calibration and validation
-    Integration of lab instruments and systems
-    Labeling and tracking of samples
-    Standard operating procedures and their use
-    Analytical method validation and documentation
-    Computer software validation
-    Records of deviations from lab procedures
-    Determination of the right QC controls, which deal with the daily quality of analytical data developed

LIMS can define specific lab personnel and their particular working environment, defining the activities they can perform and information they can access.  It offers a way to allow users to be approved to do certain functions, and the access can be limited to the information each user requires to do their job.  LIMS also computerizes the production of bar code labels when a sample is logged in, and permits the definition of storage information, like location and storage conditions, against the logged in sample.

LIMS allows for the tracking of instruments, systems, and equipment used in the lab.  It can be programmed to automatically flag and remove from operation the instruments that need regular service and calibration.  After analytical methods are defined in it, LIMS allows for the storage of the whole method description against its entry.  Each method can be programmed to show changes through time and to ensure that only the latest method is used.  Review and approval by different persons can be required before using the method.

LIMS can identify deviations in work practice and analytical data for tracking and reporting purposes.  It allows users to easily record and deal with unexpected events that inexorably happen in a lab, like sample breakage.  It can be merged will all principal instrument types in the laboratory to process results faster and to reduce errors in manual transcriptions.  LIMS has audit trailing mechanisms to record, track, and justify changes in lab data, and some even allow for the auditing of any item and the automatic sending of notifications to key individuals.

It is vital to ensure that the electronic data submitted to regulatory agencies is trustworthy, reliable, authentic and legal.  In order to comply with the 21 CFR Part 11 rule, LIMS has to provide a way to specify identification of regulatory data with the lab, audit trail mechanisms for regulatory data, security controls on the data, and mechanisms for signing electronically the regulatory data entries. This has promoted the cooperation of LIMS vendors and pharma companies to develop solutions that fully comply with this rule.

These are only some of the characteristics of LIMS that can help laboratories control and analyze data; there are many others. However, although LIMS offers a computerized secure framework for inputting, processing, and reporting information, as well as an important contribution for labs to comply with the changing regulatory requirements, it is only a part of the solution.  Pharmaceutical consultancy firms reinforce the fact that there must also be a thorough knowledge of the regulatory requirements and comprehensive QA/QC procedures.

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As the debate on whether to use stem cells, or not to use stem cells continues to rage, many people are starting to look to the potential upside of using stem cells as a deciding factor.  Stem cells have remarkable potential to be used to test new drugs, cure previously thought of as incurable diseases, and possibly cure many different types of cancer.  But the application of stem cell research has caused a heated debate over the last 20 years, and much of stem cell research was illegal until only recently.  So what are the reasons for this heated debate about stem cell research, and what are the possible applications of stem cells in the future.

You may wonder why there is any debate at all, over a medical treatment method, which may be able to cure some diseases that 20 years ago were thought of as altogether incurable.  But, as it often is, the discussion is much more complicated than it seems.  At the heart of the stem cell debate is the battle over abortion.  According to many opponents of stem cell research, using living stem cell tissue, usually from living embryos, is likened to abortion, since the embryo will be destroyed after testing.  On the other side of the argument, stem cells hold great promise for millions of families and patients thorough out the world, to cure previously incurable diseases such as Parkinson’s disease, Alzheimer’s disease, and even some forms of cancer.  But what exactly are stem cells, and how can they be used to cure diseases?

Stem cells are found all over our body in differentiated tissue and organ cells.  Stem cells are primarily used in the body to maintain and repair tissue cells, and only divide and repair when needed in case of disease or injury.  Stem cells can be found in bone marrow, brain cells, skeletal cells, blood vessels, even teeth.  Only until recently, scientists have been able to reprogram living stem cells, which provides very promising treatment options for the future.  By being able to reprogram adult stem cells the treatment of serious diseases such as cancer, and even curing blindness, are now thought to be within reach.  Even pharmaceutical firms and pharmaceutical consultancy firms are even coming out openly saying that the application of stem cells to cure disease is a real possibility and needs to be further examined.

However, there may be compromises available that will help stem cell research to move forward and into practical use.  Another method of extracting stem cells is through the process of taking adult stem cells from living blood or organs of healthy adults.  This would end the abortion issue about stem cells, and help research to move forward.  The only problem with this method is that many scientists are finding adult stem cells to be marginally helpful to scientists, and do not show the same promise as using living embryos.

Regardless of the debate over stem cell research, the practical usage of stem cells could ultimately be revolutionary in the field of medicine.  Stem cells could be used to test new drugs, they would allow for a wider range of drug testing for all kinds of drugs, including anti-tumor drugs in cancer cases.  They can be used to regenerate damaged cell tissue or even completely replace damaged tissue in the body.  It could help in the treatment, or possibly cure such diseases as Alzheimer’s disease, Crohn’s disease, diabetes, strokes, spinal cord injuries, severe burns, and heart disease.  Only time will tell what the future use of stem cells will bring to our society as a whole, but at this point many are seeing the possible, future benefit of using stem cells, outweighing any negative stigma regarding stem cell research.

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In preparation of a developing pandemic of any kind, whether it be influenza, or some other kind of fast spreading virus, the Food and Drug Administration (FDA) has devised a precautionary plan known as the FDA Pandemic Preparedness Strategic Plan.  The FDA Pandemic Preparedness Strategic Plan is coordinated with the President’s National Strategy for Pandemic Outbreaks, as well the CDC’s Pandemic Implementation Plan.  Under these guidelines the FDA works under federal and local levels to effectively contain a pandemic outbreak, if possible, and do whatever is in their power to minimize the harmful effects of an outbreak.  But what is the FDA’s Pandemic Preparedness Strategic Plan, and what does it mean to a normal citizen, like me or you?

The FDA Pandemic Preparedness Strategic Plan is a plan strategically shaped to coordinate Federal, State, and local levels of government, to work together to prepare for, and ultimately minimize the effects of a pandemic outbreak, such as the Influenza outbreak of 1918, or the recent pandemic, known as the Swine Flu.  The plan involves coordinating federal and local authorities to develop enough domestic vaccine production capacity, sufficient to provide enough vaccines to accommodate for the entire U.S. population.  The FDA would make sure that the vaccines developed are safe and effective enough to give to the population as a whole, as well as providing cross-protective immunity.

The FDA’s Pandemic Preparedness Plan also relies on the availability of improved diagnostic devices, which can be readily available, and can also detect pandemic viruses, as well as differentiate between seasonal viruses, and viruses that have pandemic potential.  This differentiation is important for not only effective patient management, but for effective pandemic preparedness and response.  The FDA will provide proper guidance to the use of the point-of-care tests, in both pre pandemic, and post pandemic phases.

However, some critics have their doubts on whether this plan can actually be fully implemented in an effective manner in case of an actual pandemic emergency event.  Critics are using such emergencies like the aftermath of Hurricane Katrina, as a catalyst of doubt, that the government can effectively handle and control a national crisis.  They are also using other national emergencies such as the terrorist events of 9-11, to point out an example of the lack of coordination between Federal and State authorities in case of a widespread emergency.  Because of these widespread doubts many citizens are taking matters into their own hands, and getting flu vaccinations on their own.

But is this FDA Preparedness Plan actually a viable option response to a real viral pandemic? Many have their doubts.  One of the major doubts people are having is whether the FDA can effectively create enough vaccines to have a real impact on a pandemic outbreak, if one were to break out unexpectedly.  The pharmaceutical industry, as well as many life sciences consulting firms, are having their doubts as well.  Upon witnessing the recent shortage of H1N1 flu vaccines, the pharmaceutical industry as a whole doubts that the FDA could effectively coordinate the mass amounts of vaccines need to quell a real pandemic outbreak.  Only time will tell, but the FDA stands firmly behind their Preparedness Response Program, and stands by its claims that it is ready for anything.

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Companies today face a unique environment, one that demands flexibility and fast response to changing business needs.  In response, many businesses have adopted virtual organizations: decentralized, team-based and distributed structures that are supported by the advances in communication technologies.

Every virtual organization is unique.  They come in all shapes and sizes, in different locations, and have no defined structure.  Such an organization can modify business processes in a dynamic way to meet market demands, to coordinate contacts, to define different boundaries over time or according to customer, and to organize components’ relationships as needed.  In order to do this, the virtual organization’s employees, teams, departments, units, or firms, must be distributed geographically, have to be functionally and culturally varied, electronically linked, and connected through lateral relationships.

Virtual organizations add value to their clients by building networks around them.  No control or direction is required; instead, these want to display processes that demonstrate leadership, coaching, facilitation, and contracting skills.

Virtual organizations help their customers by improving their own performance, careers, and personal lives.   They are collaborative organizations that acknowledge that the old hierarchy-based structures are not valid anymore.

Some fundamental values that guide the work of a virtual organization are:

-    Steady learning
A virtual organization is an educative one.  It knows that behind every true change there is belief, and the education on those beliefs will allow for a fully dynamic environment.

-    Works by example
Successful virtual organizations walk the walk and talk the talk.  Their objectives are clear and achievable, leaving nothing behind.

-    Interdependence
These organizations work to create interdependent relationships with their clients, suppliers, and everyone else related to their business.  They help companies move from dependence, to independence, where it is easier to work and add value.

-    Customer understanding
The real focus of virtual organizations is on the value of a long-term relationship, not on the worth of a short-term transaction.

-    Win/win philosophy
Every relationship started and developed by a virtual organization must be valuable for both parties.  There is no such thing as I win; you lose.

-    Respect and courtesy
The organizations show genuine respect and interest in all of their clients and partners.

These values, in turn, give birth to the following factors, which are critical for success:

-    Value
Every client must feel that they are getting much more worth than what they are paying.

-    Constant improvement
Virtual organizations are always checking their processes to ensure the clients are getting what they need and more.  They always want to do better.

-    Impartiality
A virtual organization works under the premise that all its clients are equally valuable.  Every time a possibility of partiality emerges, the clients should be informed about it and its consequences.

-    Communication
The philosophy is of constant, clear, open, and friendly communication all the time.  In order to be successful, virtual organizations require modern information technology systems 24/7.

In order to be able to survive and excel under the new market panorama, pharmaceutical companies have to implement new practices and invest in the professional pharmaceutical consultancy that will be able to guide them wisely through troubled waters.

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Under the Hatch-Waxman Act, every generic candidate has to give the holder of the approved New Drug Application (NDA) notice of the filing of the ANDA.  As soon as they receive it, in turn it files a patent infringement lawsuit that starts a thirty-month stay, making it impossible for the FDA to approve the ANDA without a final court judgment favoring the generic candidate.

With the proposed HR 1427 and HR 1548, the generic candidate has to notify the Biologic License Application (BLA) holder about the filing, however, there is no statutory stay defined if a lawsuit is filed promptly.

In regards to the marketing exclusivity, both views, the current and the proposed, are parallel, giving similar exclusivity periods.  However, most possibly, the patent litigation resulting from a follow-on biologic application will last longer than the period of exclusivity, creating the possibility of a risky launch of the follow-on biologic, where the candidate markets its product before any final judgment is given.  This will definitely increase preliminary injunction filings and appeals to the U.S. Court of Appeals for the Federal Circuit, thus, when deciding where to file suit, BLA holders have to consider the court’s track record on preliminary injunctions and if the court provides for a shorter time to trial so as to minimize the possibility of an at-risk launch.

So, under this new panorama, filled with challenges like the one above, and with lots of uncertainty, how can you be better prepared to face the new structure for approval of follow-on biologics?

President Obama has been clear in showing his support for the progress of a structure for approving follow-on biologics.  His interest is so high that the federal budget for the fiscal year 2010 includes a proposal to develop this structure.  So, no matter what the future brings, these are some considerations you must pay attention to so that you are prepared to face any future follow-on biologics approval process and any patent litigation conditions that may come along.

1.    Understand your patent portfolio
HR 1427 and HR 1548 do not mention the creation of an Orange Book equivalent for follow-on biologics, but require that the BLA holder identify relevant patents when the follow-on biologic candidates request it.  Review your patent portfolio right away to understand which characteristics of your products and processes are protected, what the scope of this protection is, when the patent term ends, and if you own or license-in the technology involved.  In addition, ask for legal counsel and pharmaceutical consultancy to start a full due diligence investigation so that you are ready to identify the patents that cover your biological product.

2.    Understand your product and manufacturing processes
Get your scientists and manufacturing engineers on board and check everything about your product and its creation process, to acknowledge if a generic manufacturer could create something different from your patents but still be biosimilar and interchangeable.  Also, it will help you determine how long it will take a generic manufacturer to develop the follow-on biologic and what problems it faces, alerting you as to when you could be hearing about an application filing.

3.    Think ahead
Since HR 1427 and HR 1548 give extensions based on pediatric studies and new therapeutic advances, talk to your teams in production, clinical research, and regulation, to see if any of these studies are possible or if new uses are being tested.  Never stop thinking about how this new legislation can affect your company and its strategy.

Although nothing is final yet, the new legislation will surely be different from the Hatch-Waxman ANDA litigation.  If anything, staying in the loop will allow you to act based on a plan established under valuable and decisive information.

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Not too long ago, a bipartisan group of senators in the United States introduced legislation that could spell big problems for the pharmaceutical industry.  The “Pharmaceutical Market Access and Drug Safety Act” is a piece of legislation being pushed through the Senate to immediately reduce drug prices for consumers, which will ultimately force the Bio-Pharma Industry to have to drastically reduce the price of drugs here in the United States.  According to the Congressional Budget committee, this piece of legislation could ultimately save the American consumer upwards to 50 billion dollars over the next decade.  However, some in the pharmaceutical industry are crying foul.

Many pharmaceutical consultancy firms are seeing this as a big headache for the pharmaceutical industry.  They see this move by the federal government as being very poorly timed, as the pharmaceutical industry, which was a booming field for so long, has started to face some major setbacks.  The pharmaceutical industry, already suffering from losses coming from cheaper, generic medicines, doesn’t know if it can take another 50 billion dollar hit over the next ten years.  Along with many important patents expiring in the next few years, and sparsely populated drug pipelines, this measure is causing plenty of headaches in the pharmaceutical industries executive branch.

Another part of the bill, that is getting less publicity, could be even more damaging to the pharmaceutical industry.  The other section of bill outlines a plan that mandates that drugs may be imported to the United States, only if they are imported from FDA approved manufacturing plants.  Now this would sound like a pretty reasonable stipulation, if the United States imported its drugs from a lot of FDA approved manufacturing sites.  But as of right now, only about 1 in every 13 foreign plants are inspected by the FDA, and some fear that in lesser developed countries like India and China, they would face an even tougher time passing inspection.

India and China are some of the fastest growing drug makers on the globe, but they are also some of the least inspected.  There is no doubt that their pharmaceutical industries would be hit hardest by this measure.  However, not everyone feels this measure has enough teeth to really make any substantial change in the quality of imported drugs.  Many critics are citing the lack of oversight in many of these foreign countries, as well as widespread corruption, and doubt that these widespread FDA inspections will really make any impact.

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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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