Ceutical Labs services

There are several distinct markets that are served by the Analytical Testing Division. They include Pharmaceutical, Nutraceutical, Medical Device, API (Active Pharmaceutical Ingredient), NDI (New Dietary Ingredient) and Post Sterilization Testing. Two of these categories, API and NDI require additional explanation. Their definitions are as follows: API -An API is an active pharmaceutical ingredient, or the actual drug substance that is added to a product. The FDA has recently begun to monitor the manufacturing of API’s as closely as the manufacture of the finished drug substance. An API manufacturer must meet all the requirements of a finished drug manufacturer in that the API manufacturer must test their raw materials, in process product and finished product against established specifications. The most important tests here are purity and impurities. The tests can include titrations, HPLC, GC, AA, and others.

Ceutical Labs has experienced personnel to assist in the development of parenteral, topical, and oral dosage forms. We can develop and fully document the entire production process. We have developed many products across most therapeutic classes.

Our global-minded regulatory affairs staff has experience in the development of submission strategies that expedite agency review. Ceutical Laboratories, Inc. provides full-service regulatory consulting for integrated planning, management and preparation of preclinical development plans, chemistry manufacturing and control (CMC) or chemistry development, and international regulatory strategies, including: