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Regulatory affairs is the function within WNB that ensures company comply with the regulations and laws that apply to the pharmaceutical industry.
The Regulatory Affairs department at WNB is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market.
It serves as the interface between the regulatory authority and the factory team, and is the channel of communication with the regulatory authority as the company proceeds, aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product.
Our Regulator Affairs department reviews all documentation from a regulatory perspective, ensuring that it is clear, consistent and complete, and that its conclusions are explicit.
Also drafts the core prescribing information that is the basis for approval, and will later provide the platform for marketing. The documentation includes clinical trials applications, as well as regulatory submissions for new products and for changes to approved products.
Our Regulatory affairs team are involved in product development from the beginning. Regulatory restraints and requirements need to be considered when drafting the pharmaceutical, preclinical and clinical development plan. Development targets and key claims have to be reviewed and adapted to regulatory guidelines and regulations.