At Regulatory Doctor, we believe in providing top-notch FDA regulatory consulting services to businesses of all sizes. Our team of FDA experts has years of experience in various industries (pharma, biotech and medtech) and can help your business overcome any challenge. From strategy to implementation for successful execution, we are here to guide you every step of the way. Contact us today to see how we can help your business reach new heights.
Product Development, Q Submission, 510(k), PMA, De Novo, IDE/IND, NDA/ANDA, BLA, CE Mark/EU, PMDA/Japan, NMPA/China, etc.
Documentation, Auditing (GLP/cGMP/QSR/ISO13485), FDA Mock Audit, FDA Inspection Preparation/Management, Regulatory Compliance
Documentation, Auditing (GCP), FDA BIMO Mock Audit, FDA BIMO Inspection Preparation/Management, Clinical Protocol Development/Review
Regulatory Compliance, FDA Inspection Preparation/Management, Import/Export, FDA Registration/Listing
Patentability Search, SWOT Analysis, Business Development, and Risk Management