fact-sheet

NDA, 505b(2) and ANDA Product Development Services

Frontage’s CMC portfolio of services spans pre-formulation, drug product formulation development, analytical method development and validation, GLP batches, GMP clinical trial materials (manufacturing, labeling, packaging, and distribution), scale up, pilot and pivotal/registration batches, and commercial manufacturing (to be ready Q3 2024).

Our formulation development experience and capabilities cover a wide range of dosage forms for IND, NDA, ANDA and 505(b)(2) filings.