Richard Poska

Richard Poska has more than 40 years of experience in pharmaceutical product development and regulatory affairs at major pharmaceutical companies, with the last 13 years focused in the regulatory CMC area. Early in his career with a B.S. in Pharmacy, he worked for >20 years in formulation, process development and manufacturing support for solid and liquid dosage forms – both new and existing products.

This deep technical expertise provides a robust scientific foundation for his experience in preparation of global regulatory submissions, from pre-IND to post-approval. Within his regulatory CMC experience, Richard has supported more than 10 legacy products and new products at all stages of the development lifecycle, interacting with regulatory agencies in meetings as well as for major submissions for US, EU, Australia, and Canada. He has developed Quality Target Product Profiles for new and existing products, identifying Critical Quality Attributes and Critical Process Controls. He has experience in serialization of products for supply chain security and development of supply chain maps, as well as drug import/export.

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