Regulatory Affairs

Our company’s main goal is developing the product portfolio and securing safe and effective products for the market. Difficulties in managing the relevant legislation can be a real challenge, therefore, our goal is to find the most appropriate solutions to regulatory issues with the Health Authorities, assessing this direction as an essential point of success of our company. Through our ever-growing partnership network, we serve as an ideal bridge to bring together pharmaceutical distributors, regulatory professionals and Health Authorities.

We offer our support starting from the application, from the registration procedure for a new drug in the market as well as the day-to-day management of regulatory issues, of any level that may be needed:

  • Medical Information (MI) and Pharmacovigilance (PV)
  • Wholesale Dealer Authorization (WDA) applications
  • Responsible Person (RP) Services
  • Regulatory services (Registration, variations, renewals)
  • Advising and counseling
  • Liaison with competent authorities on all aspects of compliance

In our company, patient safety is primary. For this reason, the pharmacovigilance department is available 24/7 to manage the reporting of drug-related side effects.

If you experience any side effects while using a medicinal product, please report it to our pharmacovigilance department on the contacts below:

  • E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
  • Tel: +355 4 560 1088
  • Phone: +355 69 709 3712
  • Reporting includes any possible side effects you may experience either mentioned or not in the Patient Leaflet. By reporting side effects you can help provide more information on the safety of the drugs.

Contact Us
Address: Autostrada Tiranë-Durrës, km.10
Kashar, Tiranë 1001, Albania
Email: [email protected]
Tel: +355 69 2092 327
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