Services to Ease FDA Regulatory Compliance

Monthly Archives: June 2019

Foreign FDA Inspections: A Guide to FDA’s Pre-Inspection Procedures June 26, 2019

The FDA stands for Food and Drug Administration. FDA is a crucial part of the US Department that is dedicated towards offering health and human services. The primary function of this organization is to oversee the production of foods, pharmaceuticals, medical devices, and other consumer products.  The development of biological commodities that are used for … Continue reading Foreign FDA Inspections: A Guide to FDA’s Pre-Inspection Procedures

A Guide to ANDA Submissions Issued By The FDA June 5, 2019

ANDA stands for Abbreviated New Drug Application. The ANDA submission is known to contains Chemistry, Manufacturing and Control information along with bio-equivalence data . The main purpose of the ANDA submission to the FDA is to review as well as ensure potential approval of generic drug the FDA. Once the drug or product receives approval, … Continue reading A Guide to ANDA Submissions Issued By The FDA

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