The United States is the world's premier hub for innovation, investment, and growth in medicinal products, medical devices, and advanced healthcare technologies, offering unparalleled opportunities for foreign manufacturers.
The United States Food and Drug Administration (FDA) enforces rigorous, science-based standards for product safety, efficacy, and quality through pathways such as INDs, NDAs, BLAs, 510(k), PMA, De Novo, and more. Navigating FDA regulations, premarket requirements, inspections, and post-market obligations requires deep expertise amid a constantly evolving landscape. MedWisdom LifeScience specializes in guiding foreign manufacturers through these complexities, providing strategic regulatory support, registration assistance, compliance solutions, and ongoing partnership to ensure products meet the highest FDA standards, accelerate market entry, and achieve long-term success in this highly competitive and rewarding market.
Get USA Compliance Support
Support for cGMP compliance, FDA QSR/QMSR implementation, quality system audits, CAPA management, and preparation for FDA inspections.
Development of ISO 14971-compliant risk management files, hazard analysis, risk-benefit evaluations, and FDA-aligned risk mitigation plans for drugs and devices.
IND/CTN submissions, FDA meeting preparation (Pre-IND, End-of-Phase, Type C), protocol development support, and clinical trial regulatory compliance in the US.
PMS/PMSR plans, MDR/MDV reporting, recall management, trend analysis, and compliance with FDA post-market requirements for devices and drugs.
US QPPV/local contact support, adverse event reporting (FAERS), IND safety reports, PADER/PSUR/PBRER submissions, and signal detection for US market.
Customized FDA compliance training, workshops on 21 CFR Parts 11/210/211/820/803/806, eCTD submissions, and ongoing education for teams and partners.
Tailored regulatory roadmaps, pathway selection (510(k), PMA, NDA, ANDA, De Novo), breakthrough therapy/fast track designation support, and strategic planning for US market entry.
Preparation and facilitation of FDA meetings (Pre-Submission, Type A/B/C, Advisory Committee), query responses, and direct liaison with FDA reviewers.
Partner with Medwisdom for expert, strategic, and fully compliant regulatory support in the United States — from FDA strategy development and clinical trial support to pharmacovigilance, quality systems, and sustained market leadership.
Contact Our USA Regulatory Experts