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Pharmaceutical consultants can be money well spent for the companies in the industry who use them, but what do they actually do?

Good Manufacturing Practices (GMP) are the regulations which oversee all pharmaceutical activity around the world to ensure that only safe drugs are produced and released for human use. Quality is assessed throughout production and to delivery. If a company does not comply with GMP the drugs they produce may need to be recalled, they can be fined or face criminal prosecution. It is business suicide to be blacklisted by GMP regulators.

The FDA or Food And Drug Administration if the governing body in the US for medicines. Whilst their authority predominantly lies on US territory, it also reaches into foreign countries if the active ingredient of an American drug is produced outside America. FDA compliance is vital for any company that has direct or indirect connections with the US medicine market.

Advice can be given by pharmaceutical consultants on legal issues too. This is necessary if a company receives a warning letter from GMP or FDA bodies following an inspection. Companies might also wish to take legal advice on distribution methods or the global medicine market.

Clinical trials are carried out on every drug that is used on people and new ingredients that are developed by researchers. The regulations which oversee clinical trials are water tight and must be adhered to as human risk is high during the trials. Animal testing must be done prior to any human testing and there are measures which must be in place. Safe trials can be carried out with the help of pharmaceutical consultants.

These are just some of the roles that a pharmaceutical consultant does for the companies that hire them. Validation, troubleshooting with new legislation and computer analysis are other features covered by consultants. For businesses and consultants, distribution is another important area.