Regulatory Services

Regulatory services 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.

We can offer:-

  • Responsible Person (RP) Services
  • Site visits and auditing
  • Wholesale licence applications
  • Attendance of Competent Authority inspections
  • Writing and amendment of SOPs
  • Regulatory advice (UK, FDA & EMEA)
  • Qualified Person (QP) services including batch release
  • Liason with competent authorities on all aspects of compliance
  • Analytical testing
  • GDP/GCP/GMP
  • Pharmacovigilance
  • Patient Information Testing
We also provide full Qualified Person (QP) services (QP Release, QP IMP Release)

Contact Us here

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Mawdsleys Pre Wholesale (MPW)
Clinical Trial Services
Patient Information Testing