Regulatory Affairs

Services relating to Regulatory Affairs are offered either standalone or alongside pre wholesale logistics services and clinical trial services. Regulatory services can be contractual or ad hoc, and are targeted to small and medium pharmaceutical companies and biotechs. Through our ever-expanding network of partnerships we are in an ideal position to bring together pharmaceutical suppliers, regulatory professionals and Competent Authorities in the most effective way.

Our full list of regulatory services;

  • Qualified Person (QP) services including batch release
  • Responsible Person (RP) Services
  • Site visits and auditing to ensure compliance with GDP/GCP/GMP
  • Wholesale licence applications
  • Writing and amendment of SOPs
  • Regulatory advice (UK, FDA & EMEA)
  • Liason with competent authorities on all aspects of compliance
  • Analytical testing
  • Pharmacovigilance

Qualified Person Services

Qualified Person Release (QP Release) is available as part Pharma.MT's Regulatory Services, which complements the company's wider offering to the pharmaceutical industry and healthcare sector. For clients without an EU presence, we have extensive experience of accepting pharmaceuticals and biopharmaceuticals into the EU, conducting QP Release and navigating the EU regulations.