Pharma Regulatory

Fast forward to market with Meditrial.

Our mission is to help you deliver life changing medicines to market with efficiency and speed. Regardless of where you are in your medicinal product development journey, we can support you at every stage to provide comprehensive services tailored to your needs. Pharmacovigilance activities are needed from the initial pre-marketing clinical trials through post-marketing studies. Together with clinical studies, pharmacovigilance represent the confirmation of the safety and efficacy profile of new medicinal product.

Trust our global experts who will assist you with regulatory aspects related to the product development, clinical trial submissions, marketing authorization and life cycle management. With Meditrial you will gain a strategic vision and expert execution to facilitate your program all over the world.

Meditrial pharma regulatory, compliance, and quality solutions include:

 

PHARMA REGULATORY

  • Due Diligence
  • CMC activities
  • Administrative/Quality/Safety Variations
  • Centralized Procedure
  • Decentralized Procedure
  • Mutual Recognition Procedure
  • eCTD submission and management
  • Scientific Information according to NCA
  • FDA meetings and submission
  • IND submission
  • Orphan drug, Breakthrough and
  • Fast-Track Applications

QUALITY ASSURANCE

  • QMS | eQMS Setup and Support
  • FDA QSIT, ISO 13485, ISO 9001
  • GxP Audit, Gap-Analysis, Compliance
  • Assessment
  • Inspection readiness consultancy and support
  • Quality system management
  • Deviation and CAPA management
  • EU MDR | IVDR Compliance
  • Post-Market Surveillance

PHARMACOVIGILANCE - PRE MARKET

  • Eudravigilance Registration
  • Safety Management Planning
  • European QPPV
  • Local QPPV
  • Serious Adverse Event (SAE) Receipt
  • SAE Management
  • Case Narrative writing
  • MedDRA coding
  • Safety information medical review
  • SUSARs/CIOMS preparation and follow up
  • Safety information submission
  • Periodic reports (DSUR and ASR)
  • Data Base reconciliation
  • Medical writing

PHARMACOVIGILANCE - POST MARKET

  • Eudravigilance Registration
  • European and local QPPV
  • Pharmacovigilance System Management
  • Case processing and reporting
  • Quality Assurance
  • PSUR preparation and submission
  • PSMF management
  • Signal detection
  • Literature screening
  • RMP preparation and management
  • Patient support program