RegSmart is able to support clients to fulfill post-approval pharmacovigilance (PV) requirements, offering strategic advice in development of your pharmacovigilance systems, including pharmacovigilance System Master File (PSMF), to obtain a system that is fit-for-purpose based on your needs and in compliance with regulatory requirements.

The development of the pharmacovigilance system should start, in good time, prior to your first marketing application in order to have a system in place at approval of the product.

Some of the challenges are to develop a well-suited system and to implement pharmacovigilance into the company quality system. We can support in different areas of pharmacovigilance to prevent those difficulties.

With long experience from government inspections and expertise in good pharmacovigilance practice, GVP, we can also perform audits of MAH, partner companies or service providers. 

Our services may include:

  • Strategic planning and advice
    – in the establishment of a new pharmacovigilance system including PSMF
    – in expansion of an existing PV-system (e.g., after purchase of new products or company mergers
  • Audits
  • Advise in implementing the Pharmacovigilance system into your quality system, including quality control of SOPs.
  • Interim assignments as QPPV/ deputy QPPV (in situations with need of extra staffing e.g., long-term absence)
  • Training and lectures in PV, including inspection readiness
  • Advice in establishment of Safety Data Exchange Agreements
  • Act as discussion partner to quality management and/or QPPV