Regulatory Consulting for Medical Device Companies
At FDAMap, we assist medical device, pharmaceutical and biotechnology companies to meet their specific regulatory and compliance requirements with respect to FDA, EMA and other international regulatory agencies. With collective experience of more than 5 decades, our regulatory and quality assurance team comprises of renowned regulatory professionals and medical device consultants including ex-FDA personnel.
Our host of medical device consultation services include but are not limited to product development strategy, regulatory strategy, device registration and licensing, predicate device search, premarket notification and clearance, clinical trial design, on-site audit and training, quality assurance and quality control, US authorized agent services, FDA and EMA meetings, pharmacovigilance, and advertising and promotions.
Our regulatory expertise and extensive experience in closely working with FDA, EMA and other regulatory bodies ensure your products comply with all standard guidelines and get speedy regulatory approval while saving cost and time. We have helped a number of medical device companies across globe to access new markets by making their products fully compliant and getting them approved timely. We also help in handling emergency situations like warnings, stern regulatory actions including product recall.
Our client engagements for medical device regulatory services range from two-hour consultation session, to fixed hours online and onsite training, on-site audits, monthly newsletter and website banner promotions, to project completion contract. We customize our offerings to suit your regulatory and compliance requirements, and medical device marketing needs.
To avail any of our services, please get in touch with us at firstname.lastname@example.org or call us at +1 410 501 5777.