An Abbreviated New Drug Application (ANDA) is an application submitted to the U.S. FDA to demonstrate that a generic drug is equivalent to a previously approved Reference Listed Drug (RLD) in terms of safety, efficacy, and quality. The ANDA contains information used for the review and approval of a generic drug product, and does not typically require preclinical and clinical trial data, but rather requires the inclusion of information on bioequivalence to the RLD.
As a specialized provider of regulatory consulting and compliance solutions, Proregulations understands that drug compliance in the U.S. is a complex and ever-changing area, and assists sponsors in adhering to strict FDA regulations to ensure rapid and compliant entry into the U.S. market.
Proregulations provides regulatory counseling for generic product development, manufacturing, registration, and distribution phases to ensure full product lifecycle compliance with FDA requirements.
Specifically, Proregulations’ ANDA services encompass the following areas:
Compliance Consulting
l Interpretation of relevant regulations and guidance
l Analyzing the feasibility of ANDA for products in the U.S.
l Developing a rational ANDA strategy
Pre-submission activity management
l DUNS/FEI application
l ANDA numbering application
l Preparation for pre-submission meeting with FDA
Gap analysis
Proregulations conducts a gap analysis of the client’s registration materials and data, and issues a detailed gap analysis report, along with specific recommendations for improvement and implementation strategies.
Drug Master File (DMF) Preparation
l APIs DMF preparation
l Excipient DMF preparation
l Packaging materials DMF preparation
Documents Preparation and Submission
l ANDA registration information list organization
l Writing and organizing all documents required for ANDA
l Review documents, product labeling and instructions
l Submission of eCTD documents in compliance with FDA requirements
Tracking Approval Progress
Follow up on the progress of the ANDA application, answer FDA questions and submit additional documents.
U.S. Agent
Proregulations submits ANDAs to the FDA for foreign applicants and communicates any FDA notices, warning letters or other important information in a timely manner.
