"CONTRACT REGULATORY & CONSULTING SERVICE"
Our background
- Long-term experience in regulatory affairs management on market of Croatia, EU and many other countries.
- Extensive experience in legislative implementation with up-to-date knowledge, participating expert discussion groups involved in legislation procedures and harmonization.
- Wide range of contacts.
Products in concern
- Medicinal products
- Medical devices
- Veterinary Medicinal Products
- Food and Feed Additives and Supplements
- Borderline Cosmetics
- Biocides
Regulatory Affairs
- From the advice on submission strategy, preparation and application for Marketing Authorization (preparation of all localy needed documents and documents in local language included), post submission support, until the post approval support and maintenance of MA.
- Posibility of contracting/subcontracting for multi-market projects.
- Packaging texts- proofreadings and harmonization of texts in accordance with the legislation.
- In the range of veterinary medicinal products the following services also included: pharmacovigillance support, monitoring in clinical / bioequivalence / residue studies, upgrading of documentation in compliance with up-to-date regulation.
Consulting:
- Advice upon local market particularities, help in local market portfolio creation.
- Bussiness and regulatory contacts.
High qualty of service and confidentiality in data management guaranteed.
