At Trimed we know a pharmaceutical company's focus is on developing the product portfolio and getting products to market. Understanding the complications involved in managing pharmaceutical regulations can be a real challenge, and finding the right partner to alleviate the pressure of satisfying Competent Authorities requirements in helping manage regulatory affairs, is key.
Our Albanian regulatory services are offered either standalone or alongside third party logistics service. Through our ever-expanding network of partnerships we are in an ideal position to bring pharmaceutical suppliers, regulatory professionals and Competent Authorities together.
We can help with every stage of a product’s life, from supporting license applications to managing day to day regulatory issues, to whatever level you need:
- Medical Information (MI) and Pharmacovigilance (PV)
- Full Quality System Implementation
- Licensing Authority applications
- Wholesale Dealer Authorisation (WDA) applications
- Responsible Person (RP) Services
- Preparation of sites for inspections
- Review & implementation of quality systems
- Regulatory services ( Registration, variations, renewals)
- Advising and counseling
- Liaison with competent authorities on all aspects of compliance
- Analytical testing
- GDP/GCP/GMP Expertise