Abbreviated New Drug Application (ANDA)

Protheragen-ING Lab specializes inproviding comprehensive Abbreviated New Drug Application (ANDA) services topharmaceutical companies. Our team of experts is dedicated to helping younavigate the complex regulatory landscape, ensuring that your generic drugsmeet all requirements for approval by the U.S. Food and Drug Administration(FDA).

What is an ANDA?

An ANDA is a submission to the FDA for a generic version ofan already approved drug product. The ANDA demonstrates that the proposedgeneric drug is bioequivalent to the reference listed drug, meaning it has thesame active ingredient, strength, dosage form, and route of administration.

Our comprehensive ANDA services

Protheragen-ING Lab offers our clients a complete range ofANDA services, including:

• Analysisof the feasibility of ANDA registration of the product in the US based on USregulatory requirements.
• Regulatoryconsulting during the product development and manufacturing stages to guide clientsin complying with specific requirements, such as product development throughQbD methodology and GDUFA program implementation.
• ANDAfile checklist sharing.
• Gapanalysis and regulatory assessment of generated source data.
• Pre-submissionmanagement activities such as facility identification, DUNS/FEI/ANDAapplication number requests, etc.
• Preparation,translation, review, and submission of ANDA registration materials in CTDformat according to current FDA and Refuse to Receive (RTR) requirements.
• Fulltracking of the official drug registration review process and communicationwith the FDA for the ANDA approval.
• Assistingclients in preparing additional/missing documents for RTR/GDUFA compliance.
• Regulatorystrategy and response preparation for inquiries, such as IRs, DRLs, or CRLsduring the ANDA approval process.
• cGMPaudits and guidance to clients to complete corrections on time.

Our Service Process

a. Initial Consultation:

We start with a thorough consultation to understand yourspecific needs and the details of your generic drug product. This helps ustailor our services to provide the most effective support.

b. Strategic Planning:

Our team develops a strategic plan for your ANDA submission,outlining the necessary steps and timelines. This includes identifyingpotential challenges and preparing solutions to ensure a smooth process.

c. Documentation and Submission:

We assist with the preparation of all required documents,ensuring they meet FDA standards. Our meticulous approach minimizes the risk ofdelays or rejections.

d. Bioequivalence Studies:

We coordinate bioequivalence studies, including study design,execution, and analysis, to demonstrate that your generic drug matches thereference product in terms of safety and efficacy.

e. Review and Approval:

Throughout the FDA review process, we provide ongoing supportand communication, addressing any queries or issues promptly to facilitate atimely approval.

Ready to bring your generic drug to market? Contactus today to learn more about our ANDAservices and how we can assist you in achieving FDA approval.