Richard Poska

Managing Director, Regulatory Affairs at Flexo LLC

Speaker

Richard Poska has more than 40 years of experience in pharmaceutical product development and regulatory affairs and is managing director at Flexo LLC, a CMC consulting firm. After earning a B.S. in Pharmaceutical Technology, his career focused on formulation and 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 product stage. Within his regulatory CMC experience, Richard has supported more than 10 legacy products and many new product candidates at all stages of the development lifecycle. He has interacted with regulatory agencies in meetings as well as planning for major submissions for US, EU, and other regions. 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. Richard’s experience also includes auditing, cGMP compliance, and performing as “agent in charge” for regulatory authority inspections. More recently he has expanded his abilities to sterile combination drug device auto injectors and pharmacy compounding.