Regulatory affairs

Regulatory Affairs department is the corner stone of Pharmassist, consisting of a team of 17 experienced professionals with more than 16 years of experience; Pharmassist ‘s Regulatory Affairs  team has provided full /ad hoc regulatory support in more than 100 clients, 40 of whom are foreign or multinational pharma companies.

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 CTD, NeeS and eCTD format for National, MR and DC Procedures
  • Provision of accurate translations of scientific documents (SPCs, PILs, training material)

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