Why you should get into contact with us
- very fast
- interpersonally and pharmaceutically competent
- experienced in organisational and regulatory issues
- available on short notice
There is a permanent shift of requirements, constraints and objectives in the dynamic environment of relevant regulatory guidelines, pharmaceutical development and clinical supplies. This continuous movement lets the context seem to be very complex and distorted.
It has been shown that the following areas bear the biggest potential for gaining efficiency:
- GxP Compliance
- Training and Coaching
PharmDev's organisation is following this insight.
PharmDev's people help you to re-align the issues and thus put them in an order which only enables a new orientation.
Each consultant with PharmDev owns a specific and comprehensive professional experience in the relevant functional areas of pharmaceutical industry and related service providers. All are either industrial pharmacists or have another adequate education in natural sciences.
US FDA requests in Code of Federal Regulations (21CFR211.34) the same as the EU does in revised Part I Chapter 2 Personnel of GMP guidelines for consultants:
Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide.
We would be happy to provide further information on request demonstrating our "education, training and experience or any combination thereof" .