Current Good Manufacturing Practices (cGMP) cGMP is required by the U.S. FDA to ensure that proper guidelines are followed in the manufacturing of active pharmaceutical ingredients (APIs), finished drug formulations and liquids are manufactured.
Most compounds or drugs must go through a stringent and elaborate process to become an approved drug. To import to the U.S., market your products must be incompliance with U.S. FDA Regulations. JAD has the actual former senior FDA investigators that conducted drug inspection in the U.S and international drug inspection all over the globe for the United States Food and Drug Administration.
It is a regulatory requirement to comply with the applicable rules and laws enforced by FDA. We can help with the development of a generic drug and design the program for importing the product to the US. We will help in drafting FDA regulatory submission for your establishment to submit to the U.S. FDA. Our FDA drug subject matter experts will advise your company on analytical methods, stability and other key area in the FDA drug approval process. There are no worries we will guide your establishment through the entire FDA approval drug process from start to finish. FDA. JAD can conduct an FDA mock inspection of your facility for compliance with Current Good Manufacturing Practices (cGMP)
Some of our services are:
- Drug Master File submission (DMF) DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market.
- IND, or Investigational New Drug Applications- INDAs are required for all new molecules that are eventually intended for use in human pharmacology products, and have already been screened in animals.
- NDA, or New Drug Applications: Drug sponsors may petition the FDA for approval of a new pharmaceutical for sale and marketing in the U.S.
- ANDA, or Abbreviated New Drug Applications (for Generics): Generic drug applications are “abbreviated”
- Assistance to meet post-approval requirements
- Meeting Support
- Labeling assistance