Strategic regulatory advice
Regulatory strategies and plans
A well-defined strategy will help bring your product to market using the fastest and most cost-efficient track – by combining regulatory goals with your market and business goals.
A well-defined strategy will help bring your product to market using the fastest and most cost-efficient track – by combining regulatory goals with your market and business goals.
A regulatory strategy is an evaluation of a product´s development pathways, options and likely regulatory outcomes. It aligns the regulatory objectives and activities with the business strategy.
A regulatory plan, on the other hand, describes the steps and actions for meeting the objectives from the regulatory strategy above. It highlights the requirements for obtaining regulatory approval and for keeping the product on the market.
Our consultants can help you stay abreast of regulations that can impact your regulatory strategy and plan. Arex Advisor can help formulate a way forward to avoid regulatory pitfalls during your product´s development phases. We have a lot of experience with helping clients formulate regulatory strategies and plans as well as identifying gaps in existing plans.
Erik Hedner
Arex Advisor AB
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Staffan Thunell
Founding partner
BSc Economics and BA
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.