Premarket Notification of Medical Devices. Uncertainties in the Regulators Letter
You could start selling or exporting a product but wait! Within the regulator's letter, there may be clauses that require critical assessment and managing the…
Invitro Diagnostics
Medical Technology Products. Medical and Regulatory Standards
Medical technology is an expansive term that implies diverse products, services, or solutions that are intended to improve health and well-being. Medical technology can include…
Health Teconologies
Clinical Pharmacology and Biopharmaceutics Data Review, Guidance and Compilation
We review, provide guidance, and assist in the compilation of clinical pharmacology and biopharmaceutics part of the regulatory dossiers. Some of the steps of our…
Medical Device
Assessment, Guidance, and Compilation for Premarket Approval of Medical Device
We review the data presented, provide guidance for the need for any further development, and help in the compilation of the data generated by your…
