Regulatory Submission Strategies and Consultation

Cirrus Pharmaceuticals is registered with the FDA as a cGMP testing facility and can generate QA reviewed, regulatory submission-ready CMC documentation. Cirrus has in-house expertise in the development of regulatory submission strategies and provides consultation as needed for US and rest of world submissions. If needed, a designated expert from Cirrus may directly consult with the FDA, EMEA, or other global regulatory agencies and attend meetings together with the clients and the agency.