Achieving regulatory approval requires more than complete documentation—it takes strategic foresight, scientific clarity, and a deep understanding of what reviewers expect. Our regulatory submission experts, including former FDA reviewers and seasoned industry specialists, guide your applications from early strategy through final approval to help you get it right the first time.
From INDs to 510(k)s and pre-submissions, we support every stage of your product’s regulatory journey. We help you select the optimal pathway, prepare clear and persuasive submissions, and engage effectively with FDA reviewers to prevent costly delays. Whether you’re seeking to accelerate a new drug, generic, or medical device, we make the process efficient, compliant, and confidence-inspiring.
With experts who have sat on both sides of the review table, you’ll gain a partner who knows what gets approved—and why. Every project is designed to minimize risk, strengthen your scientific rationale, and deliver a submission that advances smoothly toward approval.
All of our services are backed by a Total Quality Guarantee.
Leverage inside perspective to anticipate reviewer expectations and streamline approval timelines.
Ensure your data, documentation, and justifications align seamlessly with current standards.
Prepare for and lead productive FDA meetings that clarify requirements and prevent setbacks.
Our experts help you design regulatory pathways that align with business objectives and lifecycle goals.
Bring your drug to market with confidence through expertly planned and executed submissions that meet FDA expectations. Our team of former reviewers and regulatory specialists supports every stage of your drug development program—from IND preparation through 505(b)(2), and ANDA pathways. We help you craft clear, scientifically sound submissions that tell your product’s story effectively, anticipate reviewer concerns, and minimize the risk of costly delays.
Accelerate device clearance and approval with experts who understand the evolving regulatory landscape. Our former FDA reviewers and regulatory specialists guide you through every step—from pre-submission strategy to eSTAR 510(k) preparation and meeting facilitation—to help you achieve faster, cleaner outcomes. We ensure your documentation, testing, and rationale meet FDA expectations and position your device for first-cycle success.
Learn how The FDA Group deployed its staff augmentation model to support a multinational pharmaceutical company's QMS remediation efforts. This project principally included deviation and CAPA backlog activities, significant corrective and preventive remediation throughout the quality system, and extended support to assist in staff onboarding, training, and maintaining the continuity of improvements made across the QMS. The FDA Group accomplished its goal of eliminating all backlogs on time and under budget.
Learn how The FDA Group partnered with a large clinical service company to manage its QMS remediation efforts and fulfill long-term staffing assignments for two vital roles in the management of the company’s quality and pharmacovigilance functions. This case study demonstrates the value of our convenient, cost-effective staff augmentation model as a means of circumventing the administrative costs and burdens of traditional hiring.
