The pharmaceutical industry is one of the most highly regulated in the world.
In order to navigate your path successfully through the legal requirements while taking advantages of any available incentives, requires the guidance of an experienced regulatory affairs professional. Planning the development of your product should always have the end in sight while remembering to review and amend the plan in light of new information and changes in the external environment. Avoiding the regulatory pitfalls of drug development is cost-effective and time-efficient.
- Preparation of regulatory affairs strategy, in collaboration with your team
- Assessment of potential regulatory incentives for your project & company
- Assessment of potential impact of new legislation on your development plan
- Preparation and regular review of Target Product Profile (TPP)
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