Pharmaceutical companies which manufacture and distribute medicines and medical devices must ensure that they comply with current Good Manufacturing Practices or cGMP. The whole aim of GMP is to ensure a high standard of drug entering the market. Every month there is new legislation falling under cGMP because new drugs are created and technology keeps getting better. It would be impossible for a pharmaceutical company to keep up with all of these new regulations unless they made use of GMP consulting.
A company can either hire a permanent member of staff to advise it on GMP or make use of an independent consulting firm. The second choice is the winner for many reasons.
Firstly, it costs much less to hire an independent GMP consultant than it does to employ an in-house staff member. You will only need between two and four consultancy meetings per year unless there are major developments. For a full time employee their starting salary would be in the region of £60,000
Price is only one of the benefits of independent consultants. The range of knowledge of GMP consultants is vast. Their technical experience as well as their knowledge of science and drugs is immense. When you hire a consultancy firm you have access to all of their consultants so their experience will far outweigh that of an in-house person.
They advise companies on many aspects of business. They advise on communication with national and international governing bodies over audits, inspections and warning letters. If new regulations have been brought in a consultant can help with any troubleshooting. Legal issues are also something dealt with by them. Validation, which is a major aspect of drug development and GMP, can also be worked on so that companies can keep excellent records of everything they have manufactured.
It would be impossible for any pharmaceutical company to comply with every new GMP regulation if they did not use GMP consulting. What they can offer in terms of experience and knowledge is far more than any in-house employee could give them.