The pharmaceutical and medical device industries are highly regulated sectors. QbD’s life sciences experts help you to achieve full compliancy.
Align with regulations
The pharmaceutical and medical device industries are highly regulated sectors. Keeping abreast of current and evolving regulations and standards is a challenge in today’s fast moving environments and changing regulatory landscapes.
Over the years, the pharmaceutical industry has become one of the most highly regulated, second only to the nuclear and aerospace industries. The need for regulatory compliance has thus also gained in importance. Compliance is about developing and implementing internal controls and procedures that promote adherence to applicable statues, regulations and directives and other regulatory requirements1.
1) Office of the Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers., April 2003, Federal Register/Vol. 68, No. 86/ Monday, May 5, 2003/Notices.
How we support you
Contact us for more information or to request a free, no-obligation proposal.