Regulatory Affairs

Regulatory Affairs

PHARMASSIST LLC  Regulatory Affairs is your one stop service to keep track of the ever-changing legislation, guidelines and regulations. PHARMASSIST can assist you in preparing registration documents to regulatory agencies, and carrying out all the subsequent negotiations necessary to obtain and maintain marketing authorisation of your products.

PHARMASSIST can provide strategic and technical advice at the highest level of quality, during all stages of development, making an important contribution both commercially and scientifically to the success of a marketed product.

In the area of Regulatory Affairs we provide the following services:

  • Supervision and management of the Regulatory Affairs before the competent Authorities
  • Advice and guidance on registration procedures
  • Review and evaluation of administrative data or supporting documentation before submission
  • Guidance on Chemical and Pharmaceutical Development
  • Scientific writing
  • Dossier preparation for Marketing Authorization
  • Pre- and Post marketing regulatory support