Abbreviated New Drug Application (ANDA) Consulting Services

Abbreviated New Drug Application (ANDA) Consulting Services Get rapid access to the industry's best ANDA consultants and move your product to market.

Before finalizing your drug product, it is crucial to submit the concept of your new product to the FDA. The ANDA submission process can be extensive and requires meticulous attention to detail. Failing to align your product with the submission guidelines can potentially derail your project and lead to costly mistakes.

At The FDA Group, we provide comprehensive regulatory consulting assistance for ANDA compilation and submission. We've helped hundreds of companies identify and overcome the many obstacles encountered during the ANDA process and ensure a smooth approval process for their products. Contact us when you're ready to move your products to market and keep it there.

Experienced ANDA consultants

Unlike other regulatory consulting firms whose consulting bench may consist of less-experienced experts, each of our regulatory consultants has an extensive track record of success, ensuring you get the knowledge and expertise you need to gain FDA approval successfully. Simply put, we deliver better talent, faster and more cost-effectively than traditional firms.

Industry and former FDA professionals

Our consulting network contains a mix of regulatory professionals, some of whom are former FDA personnel. Their unique understanding of the FDA’s ANDA review process and expectations enables us to handle our clients' submissions with the utmost expertise and attention to detail. Our insider perspective and decades of combined experience give us the edge to help our clients navigate the complex drug approval submission process.

Unparalleled client success and satisfaction

Our 95% client success rate and 97% client satisfaction rate speak for themselves. Our clients trust in our expertise to guide them through the ANDA process. With us as your consulting partner, you'll get a refreshingly personalized approach, clear communication, and attention to detail — three elements that are becoming increasingly hard to find. It's what makes us the preferred choice for ANDA consulting services.

Why you need an expert ANDA consultant

The Abbreviated New Drug Application process is complex and can be challenging for companies, especially those unfamiliar with the regulatory requirements. Over the many years we've spent helping device firms bring their drug products to market in the U.S., we've seen companies realize they need expert help in a number of areas, including but not limited to the following:

Preparation of ANDA Submission Documents: Preparing the required documentation for an ANDA involves a complex workstream that can be time-consuming and requires a deep understanding of regulatory requirements. Preparation often involves compiling extensive data, research findings, and documentation that validate the safety and efficacy of the product. Consultants provide invaluable assistance in compiling, organizing, and reviewing documents to ensure they are complete and compliant with FDA requirements.

Quality Control and Assurance: Consultants provide guidance on implementing and enhancing quality control measures, conducting audits, and ensuring that the submission reflects adherence to quality standards, reducing the risk of rejection.

Data Integrity and Validation: Ensuring that the data included in the submission is accurate, reliable, and consistent is paramount. Consultants assist in data validation, conducting integrity checks, and ensuring that data is presented in a manner that supports the submission’s approval.

Risk Management: Identifying, assessing, and mitigating risks associated with the submission is crucial to avoid delays or rejections. Consultants help identify potential risks, develop mitigation strategies, and assist in implementing measures to manage and reduce risks effectively.

Interaction with the FDA: Consultants assist in preparing comprehensive responses, providing additional information, and addressing the FDA’s concerns effectively to facilitate the approval process.

Strategic Planning: Developing a strategic approach to the ANDA submission involves planning, insights, and tactics to ensure a smooth approval process and market success. Consultants offer strategic advice, insights, and planning support to navigate the submission process efficiently and position the generic drug for market success.

ANDA Regulatory Consulting Services

An experienced regulatory consultant is crucial in navigating your organization through the intricate process of obtaining approval for generic drugs that require an ANDA.

Our consultants ensure that this complex and detailed process is handled effectively by deeply understanding the drug and foreseeing potential hurdles. With the assistance of highly trained and experienced professionals, the approval process can be executed with a significantly higher probability of success.

Each specific ANDA consulting engagement is customized to your distinct needs and can encompass, but is not limited to:

Regulatory strategy development

Assistance in identifying the most suitable regulatory pathway and crafting a detailed regulatory strategy for ANDA development and submission.

Preparation of ANDA submission

Writing and assembling the ANDA submission with comprehensive data and documentation. This often includes incorporating detailed information on bioequivalence studies, product formulation, manufacturing processes, and quality controls.

Review and analysis of the generic drug and its Reference Listed Drug (RLD)

Determining the classification of the generic drug and identifying the applicable RLD. This includes analyzing the generic drug compared to the RLD, focusing on bioequivalence, formulation, and therapeutic equivalence.

Interaction with the FDA

Facilitating communication with the FDA, including responding to agency inquiries and requests for supplementary data.

Support throughout the review process

Navigating the complexities of the ANDA review, addressing additional data requests, and ensuring compliance with FDA’s generic drug approval standards.

Post-clearance support

Supporting the management of post-approval changes, supplements, and compliance with ongoing regulatory requirements for generic drugs.

A sample scope of ANDA consulting services

Project Initiation:

Assignment of a dedicated Project Manager.
Organization of a kick-off teleconference to introduce the team and provide an overview of the process.
Discussion of project-specific details and provision of an initial list of documents to guide filing activities.

Expert Guidance:

Provision of technical expertise in regulatory, Chemistry, Manufacturing, and Controls (CMC), administrative documents, clinical, and labeling aspects.
Development of a comprehensive project strategy.
Guidance on development activities to ensure technical content meets current FDA requirements.

Document Preparation and Review:

Guidance and review of reports and supporting documents prepared by client departments or other vendors to ensure they meet technical and format requirements.

eCTD Conversion and Compilation:

Conversion of all documents into Electronic Common Technical Document (eCTD) ready format.
Incorporation of documents into the ANDA backbone using commercial eCTD software.
Final compilation and publishing of the ANDA to ensure full compliance with FDA requirements.

Submission and Review:

Submission of the completed ANDA via the FDA's Electronic Submissions Gateway (ESG).
Provision of a copy of the final ANDA to you for your records.
Management of communications with the FDA during the ANDA review process.
Preparation and submission of responses to any deficiencies, billed on a time and materials basis.

Let's bring your product to market and keep it there.

Contact us today to take the first step toward bringing your product to market quickly and efficiently. A flawed submission will cause delays and hold up your product launch for several months—perhaps longer.

Our ANDA consultants will give you individualized support to maximize the likelihood that your submission is successful and delay-free. Our bench of regulatory affairs talent has extensive experience and knowledge, with some having worked directly with and within the FDA. They will share their expertise with you throughout the process, providing a level of service and professionalism that's hard to find elsewhere.

Our Proven Process