Why Your Biotech, Pharmaceutical or Medical Device Organization Needs an Independent Consultant
Navigating the regulatory complexities and laboratory hurdles often hindering the development journey is daunting. This is where independent consultants, such as Metis Consulting Services, play a crucial role in unlocking the full potential of your products and achieving regulatory success.
Welcome Back to the Metis Blog
In this Blog Space, we discuss topics of interest to people in our industry and what is happening here at our company. At Metis, we offer services in
Audits/Inspection Readiness, Consulting Services,*Corporate Training,*Data Management,*Pharmacovigilance,*Quality Management, and REMS.
We aim to help organizations keep up with regulatory conditions and industry best practices to ensure patient safety and access to effective therapies.
RIC, REMS, and the REMarkable Dr. Frances Oldham Kelsey
Frances Oldham Kelsey was a Canadian-born physician who fought big pharma companies and a tremendous amount of pressure to do her job. In the process, she saved lives and heartbreak for thousands of Americans.
What is this Alphabet Soup?
Although it is reasonably well understood conceptually, the REMS program is relatively new - it started in 2007- and is still in the process of being operationally understood.
Audit & Inspection Readiness
Inspections and audits allow the pharmaceutical sponsor to improve its processes and demonstrate continual improvement in every department and phase of the process.