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…
Pharmacokinetic Compatibility in Fixed Dose Combinations
For a fixed dose combination, the pharmacokinetics of individual active substances should be well documented. In general, it is required to demonstrate that the individual…
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…
Cross Discipline Review & Guidance on Pharma, Biotech, Med-Tech Products
Cross discipline review and guidance on pharma, biotech, med-tech products requires cross functional skills and expertise. During the review we includeanalysis of target or disease…
