FDA Regulatory Services
for
Pharma, Biotech, Foods & Medical Devices
Get comprehensive FDA regulatory services for drug, biologic, or medical device development from FDAMap, a leading regulatory consulting firm in the USA. Our major regulatory services include regulatory strategy and planning, document preparation and review for FDA regulatory submissions, FDA meeting requests and support, pre-market approval assistance (IND, NDAs, IDEs), and post-market surveillance and reporting. We also help in FDA audit preparation through our mock FDA audit/inspection services.
Our major regulatory consulting services
Here is a brief description of our specific services that help you comply with FDA regulations and guidelines while developing a product regulated by the FDA.
Let’s turn your regulatory goals into reality—are you ready?
Connect with us today to discover how our 20 years of FDA success can guide your next regulatory achievement.
Product Development Strategy
Developing a successful product in the FDA-regulated industry—whether a drug, biologic, or medical device—requires more than innovation. It demands a strategic, data-driven, and regulatory-aligned approach that navigates the complex requirements of the FDA from concept to commercialization. At the core of this process lies an effective Product Development Strategy, built on critical pillars such as Gap Analysis, IND/IDE-enabling strategies, comprehensive product development planning, and investment portfolio analysis. Partnering with our experienced FDA consultants ensures that you are not only well-prepared but also strategically positioned for long-term success in the competitive healthcare market.
US FDA Compliance Services
Achieving FDA compliance is crucial for bringing new healthcare products to the market. Our FDA consulting services support clients through every stage of the regulatory lifecycle. Our expertise includes preparation and submission of Investigational New Drug (IND) applications, IDE, NDA, BLA, PMA, and 510(k) applications. We ensure speedy 510k approval for medical devices and Software as a Medical Device (SaMD) through our strategic regulatory approach. We assist in Pre-IND, End-of-Phase 2 (EOP2), Pre-NDA, and other formal meetings with the FDA. We guide sponsors through the 505(b)(2) regulatory pathway, manage electronic submissions via the FDA ESG gateway, and provide comprehensive support for follow-up, queries, amendments, and successful approvals.
Quality Assurance and Quality Control Services
We offer end-to-end Quality Assurance (QA) and Quality Control (QC) services to drug and device development companies, ensuring full compliance with FDA regulations. Our team provides expert support in GMP, GCP, and GLP audit preparation, including GMP certification and process validation reviews for manufacturing processes, software systems, and analytical methods. We guide clients in developing effective strategies to respond to FDA audit findings, including Form 483 observations and inspection reports. Our services cover testing requirements, cGMP consulting for process improvement and facility compliance, and adverse event consulting for safety reporting. Whether you’re preparing for an inspection or need help with post-audit response and remediation, our QA/QC services ensure your systems meet the highest standards of regulatory compliance.
Regulatory Consulting for Clinical Trials
We offer comprehensive regulatory consulting services for clinical trials, guiding sponsors through every phase of trial planning, execution, and compliance. Our team develops effective recruitment strategies tailored to specific therapeutic areas and patient populations, enhancing enrollment rates and retention. We design and manage advertisement campaigns and targeted social media outreach to maximize visibility and engagement. Additionally, our patient support services—including toll-free helplines, online portals, and email-based pre-screening—streamline patient interaction and improve screening efficiency. Our end-to-end support ensures regulatory alignment, optimized recruitment, and a seamless clinical trial experience that meets FDA and ICH-GCP requirements.
Pharmacovigilance Services
Our pharmacovigilance services ensure ongoing safety monitoring and compliance for FDA-regulated products throughout their lifecycle. We offer robust post-market surveillance programs to detect, assess, and prevent adverse drug reactions and other safety issues. Our patient support platforms—including toll-free helplines, online portals, and email reporting—facilitate easy and timely communication of safety concerns. We provide support for Risk Evaluation and Mitigation Strategies (REMS), manage registry studies, and assist in the preparation of annual safety reports required by regulatory authorities. With our end-to-end pharmacovigilance solutions, companies can maintain regulatory compliance and protect patient safety effectively and efficiently.
FDA Regulatory Meeting Support
Our FDA Meeting Consultants meet the FDA very often about our clients’ regulatory needs. They help sponsors effectively engage with the FDA at every critical stage of product development. We provide strategic guidance and hands-on support for Pre-IND meetings, helping you present your investigational plan clearly and address regulatory concerns early. For advanced development stages, we assist with End-of-Phase 2, Pre-NDA, and Pre-BLA meetings, ensuring your submissions are aligned with FDA expectations. Our team has extensive experience preparing for and managing Type A, B, C, and D meetings, including drafting briefing documents, mock meeting preparation, and regulatory communication. With our expert consultants, you’ll be well-prepared to navigate FDA interactions and gain the clarity needed to accelerate your development and approval timelines.
US Authorized Agent Services
Our US Authorized Agent Services provide a critical link between foreign manufacturers and the US FDA, ensuring smooth navigation of the complex regulatory landscape. As your authorized representative, we act on your behalf in all communications with the FDA, handling key activities such as facility registration, product listing, import-export certifications, and regulatory filings required for market entry and compliance. We support both drug and medical device companies in securing the appropriate licenses and approvals, while maintaining ongoing compliance with evolving FDA requirements. With our expert FDA guidance, international companies can confidently operate in the U.S. market without delays or compliance issues.
European Medicines Agency (EMA) Compliance
We provide comprehensive support for EMA compliance, helping pharmaceutical and biotech companies navigate the complex regulatory framework of the European Union. Our services include the preparation and submission of Investigational Medicinal Product Dossiers (IMPDs), Marketing Authorization Applications (MAAs), and strategic representation during EMA meetings and regulatory audits. We also assist in the development and execution of regulatory strategies, ensuring alignment with EU requirements for successful product development and approval across European markets.
