Regulatory challenges vary at each stage of product development – when to interact with healthcare authorities, is a pediatric development plan necessary, are clinical trial results adequate for both regulatory approval and market access, etc.? We recognize the importance of strategic analysis and decision-making in drug and medical device development. Our tailed solutions adapted to your product development stage help to successfully tackle the challenges, proactively.

We guide you throughout the complex regulatory landscape  and complement your own resources, from product development strategy to market authorization and reimbursement.

A site of people-powered solutions throughout development and commercialization

We help define the roadmap to the market for health products, complete with situation audit, milestones, and the strategy needed to drive tangible results in line with corporate objectives.

We lead communication with regulators & payers. We author or review submission packages, anticipate questions from health authorities, and provide a rationale to support clients’ position before regulatory agencies and health technology assessment bodies. We are our client’s representative before health authorities. Development strategy & planning.

Regulatory Science

Find out how to prepare a drug registration for the US and the EU: Parallel or sequential applications?

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