The challenges facing today’s biopharmaceutical and medical device companies are greater than ever; and this industry has a huge impact on both the human and animal populations.
On June 30, 1906, the US government created the Food and Drug Administration, or the FDA, to provide oversight in the approval of drugs and medical devices as safe for human and animal usage. New innovations are being developed all the time, but not all of them make it to the market. The US market alone has more innovations in these areas than any other country in the world with over:
- 7000 Pharmaceutical companies
- 6500 Medical Device companies
- 1000 Biotech companies and
- 7100 Nutraceutical companies
Pharmaceutical companies develop, produce, and market drugs or pharmaceuticals licensed for use as medications for humans and animals.
A medical device is an instrument, apparatus, implant, in vitro reagent, or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).
Biotech or biotechnology is technology based on biology. Biotechnology harnesses cellular and biomolecular processes to develop technologies and products that help improve our lives and the health of our planet.
Nutraceutical comprises food, or parts of food, that provide medical or health benefits, including the prevention and treatment of disease. These are your supplements.
The FDA has stringent compliance regulations that companies must adhere to. Without approval, these companies cannot market their products. The risks posed by third party relationships (vendors, suppliers, agents, distributors, resellers, etc.) are huge and often go unaddressed. Regulations continue to increase as businesses become more global, and more and more companies are looking to proactively address these risks.
It is vital to have resources who understand how these regulatory requirements can impact your business; who are experienced in identifying risks and gaps; and who can implement solutions that achieve compliance, ultimately enhancing your business operations.
It’s common to feel like you’re drowning, struggling to keep up with all of the new policies added every year by governing bodies like the FDA, ICH, or EU. You may worry about the fines, penalties, and even severe legal actions that one small infraction could impose. It can be overwhelming, but it doesn’t have to be. Whether it is the writing of a simple SOP, IT compliance, moving your product globally or staffing and managing global projects, you can proactively take steps to implement comprehensive solutions that will simplify your regulatory compliance.