REGULATORY AFFAIRS

Regulatory Affairs

Pharmaceutical product development to commercialization involves many steps which are governed and regulated by national and global Health Authorities (e.g. Infarmed, EMA, FDA, etc.). Ensuring compliance throughout the entire process is a mandatory requirement and to overlook the procedures across the product life cycle, organizations deploy proven experts for Regulatory Affairs.

The regulatory team acts as a crucial link between organization and national and global Health Authorities, tracking all the key regulations related to the product and pre-requisites for its launch.

How can we support your business?

Stepwise guides and assists Pharmaceutical and Life Science companies in the design and implementation of innovative and global regulatory strategies in order to expedite product development and registration of pharmaceutical product, cosmetics, food supplements, medical devices, and other healthcare products for all stages of development.

These services includes all product development stages from Research and Development (R&D) to Commercialization with strategy advisement of each product and for the market they aim to serve.

check all stepwise services here

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