Regulatory Assistance

GK CMO will specialize in the development and contract manufacturing of biologics and biosimilar, and pharmaceutical products. We aim to help clients enter the U.S. market by providing the development, manufacturing and regulatory approval services with the Federal Drug Administration (“FDA”) and other regulatory agencies for pharmaceutical companies. The services will range from Phase I studies to commercial manufacturing operations.

GK CMO with its vast regulatory experience can help in the submissions of ANDA and 351 (k) with the FDA.