Regulatory affairs

Regulatory Affairs department is the corner stone of Pharmassist, consisting in a very large Team consisting of 18 experienced professionals, with over 20 years of experience. Pharmassist's Regulatory Affairs Team a lengthy experience in providing full/ad hoc regulatory support to multinational companies and SME. The main strategy of this department is to provide scientific, legal and strategic advice for the development, manufacturing, licensing, marketing and compliance of medicinal products with current local and EU regulations. Pharmassist’s Regulatory Affairs department has over 100 established collaborations with more than 40 of whom are top multinational pharma companies. For more than 10 multinational pharma companies, Pharmassist functions as their sole RA representative, providing full regulatory support.

Registration and Life-cycle management of marketing authorisations

  • Collection of technical data and scientific writing of chemical and pharmaceutical documentation
  • Preparation of registration dossiers in eCTD format for National, MR and DC Procedures
  • Provisions of accurate translations of scientific documents (SPCs, PILs, training material)
  • Coordination and execution of all activities pertaining to the registration and life-cycle management of marketing authorisations of medicinal products
  • Preparation of complete dossiers for submission across Europe for Full or Abridged Marketing Authorisation, Bibliographic, Hybrid, Generic & Clinical Trial Apps, and apps for Herbal Medicinal Products & Investigational Medicinal Product Dossiers

Non-pharma products

  • Biocides
  • Cosmetics
  • Medical Devices
  • In-vitro diagnostics
  • Food Supplements


  • Supervision and management of promotional activities

Pricing & Market Access

  • Provision of advice and handling of Pricing and Reimbursement issues