Bridging your regulatory needs to pharma solutions

  • Regulatory affairs

    For companies in the healthcare and pharmaceutical sector
  • Pharmacovigilance

    Monitoring of your products’ safety profile as well as medical literature for identifying potential adverse reactions
  • Information

    Timely information on all new requirements and updates in medicinal products legislation and pharmacovigilance amendments
  • 1
  • 2
  • 3

Pharma Support Services

As a specialized service provider Pharma Support Services is created to find answers to your regulatory queries and help your pharma business achieve compliance with the local requirements on the Bulgarian and Romanian markets. Taking care of all aspects from dossier evaluation through regulatory approval to post authorisation support we are ready to provide our expert advice at every step you need it. Once on the market you take care of selling your product, we take care of its regulatory compliance and safety concerns.

What we offer

Pharmacovigilance services

  • EU QPPV services (Registration in the EudraVigilance database, ICSR/SUSAR reporting, XEVMPD - electronic submission of information on medicines)
  • Collecting, processing and evaluation of ICSRs (Individual Case Safety Report) as well as reporting of serious ADR (Adverse Drug Reaction) to EudraVigilance.
  • Local contact QPPV (Bulgaria and Romania) and related Pharmacovigilance services to support Marketing Authorisation Holders (MAH) for achieving compliance with EU regulatory requirements (Regulation 1235/2010 and Directive 2010/84/EC) and local obligations to assign a local point of contact for pharmacovigilance for every registered product.
  • Literature screening and follow-up assessment of relevant articles/scientific extracts. Medical review of cases in literature can help you identify important signals concerning the safety profile of your products.

 

If you wish to report an adverse event, please use our "Contact Us" form. Thank you. We will revert to you as soon as possible.