Regulatory Affairs

Regulatory Affairs
Product Description

Inpharmatis offers comprehensive regulatory affairs services to Life Science Industry including Drug Development and Vigilance Services to pharmaceutical, medical device, food supplements, cosmetic and biotech companies. Our area of expertise lies in the European & CIS market, however though our network of credible partners we are able to manage also US, Latin America and selected RoW procedures. A multi-disciplinary team of qualified regulatory affairs consultants is at your disposal for all aspects of your marketing authorisation applications for active substances and human medicinal products. Inpharmatis shall provide full regulatory support over the whole life cycle of your product. - Advise on regulatory submission strategy - Development of regulatory strategy for the product’s life cycle- Submission preparation / review, filing and management - Regulatory Strategy Consulting - Filing and product life cycle management

Inpharmatis

  • LV
  • 2018
    On CPHI since

Inpharmatis

  • LV
  • 2018
    On CPHI since

More Products from Inpharmatis (2)

  • Pharmacovigilance services

    Product Pharmacovigilance services

    Services of EU QPPV, Local QPPVPharmacovilgilance System Set up and Review servicesICSR managementOn-going monitoring and signal managementLiterature surveillance servicesRisk managementReporting – Product Safety Update Reports (PSURs) – Periodic Benefit-Risk Evaluation Reports (PBRERs) – Development Sa...
  • eSolutions

    Product eSolutions

    Our eSolutions services include consulting services in all areas of Regulatory Operations, e.g. transition to electronic submission, compliance with EU eSubmission Roadmap, submission process optimisation, implementation of efficient Regulatory Information Management (RIM), compliance with XEVMPD and IDMP ...