Regulatory Affairs Consulting Services at a glance

The design and manufacturing of novel, innovative medicinal products involves considerations not only of manufacturing but also of quality and regulation. These are presented as required part of the development process - CMC, preclinical and clinical studies. 
New medicinal products are often biotechnology-derived products for complex therapeutic or prophylactic purposes and demand specific Regulatory requirements in product development and licensing.
Almost always individual decisions must be made and careful steps must be taken for each unique investigational product.

Regulatory outsourcing services

To help you develop your investigational product or to maintain your medicinal product throughout its lifecycle, I will guide you through Regulatory strategy and compliance.

My services are but are not exclusive to:
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Marketing authorization applications

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Orphan drug designations

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Life-cycle maintenance

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Other services

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