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
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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

Translation and proofreading services

Our experts can support your pharma business with professional translations into and from English, Bulgarian and Romanian languages. Our range of services includes:

 

  • Accurate medical translations
  • Quality control/proofreading of translated documents
  • PI adaptation/preparation according to current version of Quality Review of Documents (QRD) templates
  • SPC, PIL and Labelling preparation/proofreading
  • Labelling and mock-up preparation and check prior printing
  • Linguistic reviews of regulatory documents, product information (SPC, PIL, artworks)


We do keep your deadines so that your project is always on time.