Regulatory affairs


Friendly Life Science colleagues
Together- PharmaRelations values


As the market leader within the Nordic region, we can provide you with any solution needed for your PV system.

We can offer you skilled and experienced junior, mid, and senior consultants part-time, full-time, or assistance in recruitment into your company.

Our clients vary from small to medium to big global life science companies and the assignments can vary from national, and regional to global responsibilities.

We cover competencies within both human and veterinarian pharmaceuticals, medical devices, cosmetics, and food supplements.



  • Set-up, development and maintenance of PV system incl. QMS
  • EU and UK QPPV, dQPPV, local responsible PV person
  • Medically trained person: Physician, Veterinarian
  • Audit strategy, riskbased planning, program and plan
  • Audit of your PV system, local affiliate, partner or service provider
  • Inspection readiness and support
  • Gap analysis
  • PV intelligence
  • Training
  • PSMF
  • RMP, RMM
  • Line management, Mentorship

Life Science consultant concentrated

Full, part time, per hour, per project solutions

Qualified Person responsible for Pharmacovigilance

Provision of QPPV, deputy QPPV.

Medically Trained Person

Provision of Physician or Veterinarian including 24/7 coverage.

National Contact person for PV

Provision of National Contact person for PV.


Audit of your PV System, Local Affiliate, Partner or Service Provider. Creation of Audit Strategy, Riskbased Planning and Program.

Management team at PharmaRelations


Inspection readiness. Support before, during and after your Competent Authority Inspection by a former PV Inspector.

PV System

Gap analysis, set-up, development and maintenance of your PV System.

Quality System

Gap analysis, set-up, development and maintenance of your Quality Management System (QMS).

PV System Master File  (PSMF)

Creation, update and maintenance of the PSMF.

Written Instructions

Creation, update and maintenance of Standard Operating Procedure (SOP), Working Instruction (WI) and Templates etc.

Signal Management

Signal evaluation and handling including Signal Detection, Validation, Assessment, Prioritization and Actions.

Risk Management

Creation, update and submission of Risk Management Plan (RMP). Creation, implementation and tracking of Risk Minimization Measures (RMM).

Aggregate Reports

Creation and submission of periodic safety reports such as Periodic Safety Update Report (PSUR) and Annual Report (AR).

Growth - PharmaRelations values

Computerized systems

User Requirement Specification (URS), due diligence, Computer System Validation (CSV).

Literature Search

Global and Local literature search.


Vendor assessment, negotiation, set-up and maintenance of contracts, vendor management.

Case handling

Collection, validation, triage, follow-up, data management, coding, quality management, evaluation, submission and archiving.

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