Medfiles USA provides a wide range of services for the pharma, biotech, medical device and food industries.
From development to product registration and maintenance, Medfiles USA assists with meeting regulatory challenges through proven strategic guidance at every stage of the product lifecycle. Offering regulatory services for pharmaceuticals, medical devices, IVDs, food and feed products, as well as cosmetics, our personnel undergo continuous training and keep pace with the latest regulatory requirements and practices to ensure clients receive services of the highest quality.
Human and Veterinary Medicines
Combining the necessary academic education with real world work experience in the pharmaceutical industry and regulatory authorities, our team of professionals understand the rigors of regulatory compliance and help clients to maximize value in bringing human and veterinary medicines to the market. Whether representing big pharma, SME, or an academic research organization, we support a variety of regulatory duties along the lifecycle of medicines and herbal medical products.
Medical Devices and IVDs
From regulatory strategy to assistance with FDA submissions, CE marking processes and other regional product registrations, our experts are adept at navigating the unique challenges present with medical devices and IVDs. Proficient with clinical evaluations and performance evaluations, quality management, post-market surveillance and vigilance, our team has full capability to meet diverse requirements.
Food & Feed and Cosmetics
With expertise in regulatory positioning and launch strategy solutions, documentation assessment, preparation and submission of dossiers, as well as packages and labeling, for existing food and feed products to food and feed innovations, our team has extensive experience supporting non-drug products globally. Our competency also covers cosmetic ingredients and cosmetic products as well.
Our team of clinical research professionals bring decades of experience working with regulatory authorities worldwide including the FDA and EMA. With Medfiles USA as your partner in pharmacovigilance, you can rest assured that all levels of safety data will be handled with the utmost care and attention to detail. Our US-based team is ready to handle your PV needs, and has the additional support as well offered by our offices in Finland, the Baltics, and Japan.