CCSA Regulatory Affairs
CCSA has developed and implemented strategies to help our clients achieve clear-cut clinical development plans, successful clinical trials, and marketing approvals. We have worked with private sector pharmaceutical, biotechnology and device companies ranging from virtual to industry giants. Our regulatory affairs support services have included successful support in preparation and management of INDs/NDAs in traditional and eCTD format, IDEs/Pre-Market Notifications 510(k), PMA applications, and DMFs held by government and private sponsors. We have had successful interactions with FDA’s Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health, and Center for Biologics Evaluation and Research. In CDER, this experience has encompassed the Divisions of Drug Oncology Products, Antiviral Drug Products, Gastrointestinal and Coagulation Drug Products, Metabolic and Endocrine Drug Products, Pulmonary and Allergy Drug Products, Reproductive and Urologic Drug Products, and Dermatology and Dental Products. The types of agents have ranged from marketed drugs proposed for new indications, to known chemicals not previously approved as drugs, to dietary supplements and botanical extracts for disease indications, to new chemical entities, vaccines, and other biologics. Our experience with devices and diagnostics has included several imaging modalities (PET molecular probes, MRI, and optical imaging) and microarray technologies. In addition to direct interaction with US and foreign regulatory agencies, CCSA has prepared numerous publications and other documents on drug and device development strategy.
CCSA has developed and implemented strategies to help our clients achieve clear-cut clinical development plans, successful clinical trials, and marketing approvals. We have worked with private sector pharmaceutical, biotechnology and device companies ranging from virtual to industry giants. Our regulatory affairs support services have included successful support in preparation and management of INDs/NDAs in traditional and eCTD format, IDEs/Pre-Market Notifications 510(k), PMA applications, and DMFs held by government and private sponsors. We have had successful interactions with FDA’s Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health, and Center for Biologics Evaluation and Research. In CDER, this experience has encompassed the Divisions of Drug Oncology Products, Antiviral Drug Products, Gastrointestinal and Coagulation Drug Products, Metabolic and Endocrine Drug Products, Pulmonary and Allergy Drug Products, Reproductive and Urologic Drug Products, and Dermatology and Dental Products. The types of agents have ranged from marketed drugs proposed for new indications, to known chemicals not previously approved as drugs, to dietary supplements and botanical extracts for disease indications, to new chemical entities, vaccines, and other biologics. Our experience with devices and diagnostics has included several imaging modalities (PET molecular probes, MRI, and optical imaging) and microarray technologies. In addition to direct interaction with US and foreign regulatory agencies, CCSA has prepared numerous publications and other documents on drug and device development strategy.