Regulatory Services

We offer regulatory services which make possible efficient partnerships and unconstraint distribution

Regulatory Affairs Management

We put at your disposal a dedicated team exclusively handling regulatory affairs

  • National procedures
  • Centralised procedures
  • Mutual recognition procedures
  • Decentralising procedures
Inside Rejsi farma Pharma Distribution
Approved market authorisation

Market Authorisation

Detailed information about all necessary procedures for securing Marketing Authorisation
  • Application (renewal, extension, expansion)
  • Documentation requirements (deadlines, fees, other special requirements)

Preparation of Dossiers

  • Collection / maintenance of all documents
  • Translation of PIL (if requires)
  • Submission of dossiers at NAMD

Regular updates for all procedures steps and any regulatory changes

Market Evaluations

  • Market capacity (pharmacies, hospitals, third parties) & possible competitors
Rejsi Farma Regulatory Affairs

Regulatory affairs specialists at your disposal

RejsiFarma can help your company succeed with your pharmaceutical products in the Albanian market. RejsiFarma is the largest player and most well know actor in the pharmaceutical distribution landscape. RejsiFarma is proud to offer to its partners a team exlusively dedicated to regulatory affairs, to help you process your procedures properly and efficiently.

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