Clinical Regulatory Affairs

Reliable Regulatory Expertise from Early Development and Beyond

Reliable regulatory expertise and robust authority liaison experience from early development and beyond are essential factors for the end goal of commercial success of any pharmaceutical or biotechnology product. ProPharma Group has a unique competence and extensive experience in creating innovative regulatory strategies for all phases of product development.

Our Regulatory Affairs (RA) specialists support your clinical and medical activities by combining scientific understanding in these fields with knowledge of regulatory procedures. We work together with your physicians, clinical pharmacologists, safety officers, and medical directors, guiding them through the regulations and facilitating discussions between the development teams and regulators. We put scientific progress and goals into context of obtaining and maintaining regulatory product approval.

ProPharma Group provides clinical and medical RA services in the clinical development phase, as well as in the postmarketing phase of a product.

Our clinical and medical RA experts will:
  • Define and lead planning and execution of regulatory strategies
  • Manage and execute clinical efficacy and safety-related regulatory submissions
  • Ensure the scientific message and study results are heavily incorporated across the submission dossier
  • Lead project management and authoring activities of global and local product information