Regulatory Affairs Dpt.
expertise in international regulatory requirements
PROVET’s Regulatory Affairs Dpt. keeps track and is promptly informed of the legislation within the EU, Greece and all the regions in which the company wishes to distribute/ register its products. Further, it provides advise on the legal and scientific restraints and requirements, collects and evaluates the scientific data that their research and development colleagues are generating. Moreover this department gives technical advice right from the beginning of the development of a product and is involved in the approval of packaging and advertising material before they are used, making an important contribution both commercially and scientifically to the success of a development program and to the company as a whole.
The registration data prepared for one country frequently fail to meet the requirements for another. Consequently the Regulatory Affairs Dpt. is responsible for the presentation of registration documents to Regulatory Agencies, and carries out all the negotiations necessary to obtain and maintain marketing authorizations for the products concerned.
PROVET's Regulatory Affairs Dpt. has strong experience in international regulatory requirements:
- Registers successfully products (data collection, preparation and submission to Regulatory Agencies) in EU (National procedure (NP), Mutual Recognition Procedure (MRP), Centralized Procedure (CP) and Decentralized Procedure (DCP)) and NON-EU countries.
- Assists in developing procedures to ensure regulatory compliance.
- Interfaces with competent Regulatory Agencies in Greece and abroad.
- Remains current with local and international regulations.
- Participates in audits.
GLP, R&D
more than 80 studies have been conducted
GLP test unit can support and conduct the following studies:
- Determination of active substances and their metabolites in biological fluids for Bioequivalence, Bioavailability and Pharmacokinetic studies.
- Residue depletion studies in animal tissues and animal products (for the establishment of the withdrawal period)
PROVET's R&D department conducts researches which are exclusively based on existing molecules. R&D is mainly focusing on:
- New applications for existing active ingredients
- Improved animal-friendly formulations (solutions, suspensions, powders, tablets)
- New indications
- Development and validation of new analytical methods for the control of raw materials and final products.
- Preparation of registration dossiers for new products or renewal of dossiers for existing products.
- Stability studies, including protocols according to VICH guidelines
Logistics
specialization – customer service excellence – cost efficient
PROVET's long-term experience in Logistics Management, in animal health and pet food & accessories sector, has contributed effectively in understanding the specific needs of the market and also developing flexibility and adaptability on the achievement of storage and delivery of our products timely and cost efficient.
Third-Party Logistics' (3PL) main objective is to provide services on warehousing and distribution, or part of them, to customers by ensuring a high quality of service. PROVET's main principle is that: "the product must be delivered to the end user on time, at minimum cost, with customer service excellence and by a specialized team".
Partnerships
PROVET is currently cooperating with some of the leading companies on this sector, such as: BAYER, PFIZER, CEVA, ALPHARMA, FARMAZAC SYNVET. PROVET by possessing modern facilities and experienced scientific personnel, is constantly looking for new partners and focuses on developing new contracts for rendering services.