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Regulatory Expertise

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Our regulatory affairs team has competence in global regulatory affairs activities. We have a broad range and depth of experience in coordinating, managing, and filing regulatory submissions. Experience in multidisciplinary projects, excellent relations with regulatory authorities, and a deep knowledge of legislation and regulatory environment are some of the major strengths of our department. Our regulatory submission expertise is derived from our team's experience in filing numerous successful IND’s (CTX) and NDA’s (MAA), while employed by major US and European pharmaceutical companies, prior to joining Agno. In the past six years, we have successfully filed over ten DMFs for Chinese API manufacturers, in support of our client's ANDA and 505(b)(2)-NDA submissions.
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Chemistry Process & Manufacturing
High Potency APIs
Analytical Development
Sourcing & Logistics