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

Cosmetic products notification services

If you are looking for a local representation of your cosmetic products in Bulgaria and Romania you can rely on our professional approach to notification and follow-up of your product.

Your product as well as its labelling and leaflet should comply with Cosmetics Directive 76/768/EEC, Regulation (EC) No 1223/2009 and with Bulgarian legislation on information which is mandatory for cosmetic product's leaflets and packaging (local regulation № 36 from 30.05.2005).

As part of this service we also prepare translation and adaptation of your labeling, packaging and leaflet text so that it complies with the latest requirements. Alternatively adaptation of existing text is also possible.