Regulatory consulting
We offer regulatory advice from proof of concept to registration. Our aim is to assist with bringing new products faster to the market. Development projects have a higher probability of success if regulatory advice is sought at the point of proof of concept. Many fish products are eligible for a limited market status which can accelerate the time to market. We can provide advice to SMEs on accessing services design to support small businesses to bring innovative products to market.
Contact usAdvice on trial design
We provide scientific advice on trial design in compliance with prevailing regulatory guidelines. Trials for fish can be complex with multiple factors impacting the results. We have a proven track record of designing trials that meet the needs of regulatory submissions for aquaculture species.
GAP analysis
We provide gap analysis of existing data packages to examine their suitability for submission to the desired regulatory authorities. We can provide advice on the most efficient and cost-effective way to close any gaps to allow a successful registration.
Dossier compilation and management
We assist with preparation and submission of regulatory documentation for application of marketing authorization. We also offer assistance with post approval regulatory updates and handle variations and renewals.
Detailed and critical summaries
Detailed and Critical Summaries (DACS) are a requirement for an EU/EEA compliant dossier. VESO have veterinarians who can prepare clinical DACS and have access to a network of experts who can provide manufacturing and toxicological (human and environmental) DACS as required.
Routes of registration
We provide advice on routes of registration in the EU/EEA (national procedure, mutual recognition, centralized and decentralized procedure) and submission management.
Consultancy with regulators
We provide support for meetings with regulators in the EU/EEA and third countries and requests for scientific advice or limited markets in the EU/EEA.
Do you have a question?
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