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EU REGULATORY STRATEGY

Donawa Lifescience Consulting (DLC) works with both early stage and established pharmaceutical and biotechnology companies to help them develop an effective regulatory strategy, allowing new drugs to reach the European market in the shortest possible time.

• We understand company challenges, milestones and deadlines, and can either review or help establish a regulatory strategy to provide the best chance of gaining European marketing approval while meeting the company's business objectives.
• Which is the most appropriate route for marketing authorization - centralized, decentralized, mutual recognition or national? DLC can help you decide the best process to follow to reach target markets as quickly as possible.
• We can communicate on your behalf with the relevant European regulatory authorities, including the European Medicines Agency (EMEA).
• For non-European companies seeking to expand sales in Europe, we can analyze current marketing authorizations and plan the most efficient strategy to reach the remaining European countries.
• For small companies, we can help with SME (small and medium size entity) status requests to the EMEA, in order to obtain significant discounts on agency fees.
• Once the product is on the market, we can provide support in maintaining compliance with constantly evolving regulatory requirements, to forestall problems which could affect marketing success.