MedTech | BioTech | Nutraceuticals | Pharmaceuticals | Drug Delivery | Digital Innovation | Data Management | Health Software Medical Software
Regulatory Strategies and Market Access
FDA: PMA Supplements (including 30 Day Notices), clinical trial IDEs, 510(k)s, 513(g) requests, Digital Healthcare, Medical Apps, De Novo submissions including artifical intelligence.
EU Commission-Notified Body: Technical Files/Design Dossier-CE MARK, MDD/IVDs, MDR/IVDR, and Clinical Evaluation Reports (CERs).
Health Canada: Medical License Applications for Class I, Class II, Class III, and Class IV Devices. Medical Device Single Audit Program (MDSAP).
Brazil: ANVISA Approvals
China: NMPA Approvals
Japan: PMDA/MHLW Approvals
Korea: KFDA Approvals
Our promise
Our highly qualified experts will complete any task fast and reliably.
We guarantee fast and discrete handling of all your business tasks by our team of highly qualified subject matter experts. Our SMEs are always available – because your satisfaction is our highest priority.
Expertise
Regulatory Compliance | Clinical Affairs | Quality Assurance | Project Management | Data Management |
Digital Innovation | Health Software | Medical Software |
Consultants have worked at Medtronic, Becton Dickinson, Smiths Medical, Stryker, Johnson & Johnson, Catalent Pharma, Philips, Cardinal Health, Marrow Donor, and United Health on Regulatory compliance, Marketing, Strategies, Clinical affairs, Project management, and Quality projects covering USA, European Union, Asia Pacific, Latin America, China, Korea, Japan, and MENA.
Category:
Advanced Surgical Technology | Cardiovascular | Diagnostics | Diabetes | Digestive & Gastrointestinal | Digital Healthcare | Digital Innovation | Ear, Nose and Throat (ENT) | General Surgery | Health Software | Medical Software | Neurological | Patient Monitoring | Oral Maxillofacial & Dental | Respiratory | Spinal & Orthopaedic | Surgical Instruments | Urological | Business Strategy | Opportunity Evaluation | Commercialization Strategy | International Market Development
