Abbreviated New Drug Application (ANDA) Consulting Services

Precision and speed in the generic fast lane

Generic drug approval through the Abbreviated New Drug Application (ANDA) pathway demands perfection. With multiple competitors racing toward the same opportunity, success belongs to those who submit first, avoid deficiencies, and achieve approval fastest. One incomplete section, failed study, or quality issue can push you from first-to-file to also-ran.

ANDA excellence requires more than following guidance. You need strategies for complex formulations, solutions for bioequivalence challenges, and approaches that anticipate FDA questions. From controlled substances to complex generics, each product presents unique hurdles that can make or break market entry.

Our ANDA team includes former FDA reviewers and industry veterans who've filed hundreds of successful applications. We know what triggers refuse-to-receive actions, what causes delays, and what gets you to approval fastest.

We guide your generic drug product from concept to approval with precision across every phase—minimizing risk, avoiding delays, and supporting a successful first-cycle review.

Formulation, Development and Testing
- Support formulation development and Q1/Q2 equivalence
- Design bioequivalence (BE) and comparative dissolution protocols
- Guide method validation, impurity profiling, and container closure selection
- Coordinate stability studies, extractables/leachables, and environmental assessments
BE Studies and Data Compilation
- Draft BE study protocols with statistical justifications
- Coordinate with CROs or internal teams for study execution
- Analyze results and prepare study reports that align with FDA expectations
- Troubleshoot atypical PK results or borderline BE outcomes
Manufacturing and Facility Readiness
- Prepare manufacturing process documentation and validation protocols
- Assist with equipment qualification, batch records, and scale-up guidance
- Perform facility readiness assessments for PAI (pre-approval inspection)
- Ensure alignment with DMFs and reference submissions
Submission and FDA Interaction
- Compile and format eCTD modules, ensuring completeness and consistency
- Review for common Refuse-to-Receive (RTR) risks
- Respond to deficiencies and information requests post-submission
- Support post-approval change management and lifecycle planning

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