New Medical Device or Invitro Diagnostics
We first review and make an assessment to exclude that the product does not predicate or a possible reference product available legally in the market.…
Predicate Medical Device or Invitro Diagnostics
We make extensive national databases and regulatory requirements to ensure we can follow the least burdensome path for marketing the product. We assist with appropriate…
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…
Medical Technologies. Anticipation of the Current-Future Regulatory Framework and Credible Data
Medical technologies have increasingly raised the hope of quick, inexpensive, user-friendly platforms with the possibility of improving the way healthcare is managed. Medical technologies are…
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…
Failure to Move Forward. High Attrition Rate in Pharma Biotech
The high attrition rates in pharma biotech are well documented. Many initial laboratory studies fail to replicate the results, apart from scientific causes, artifacts induced…
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…
Pharma
Pharmacology Review Before and During a Product Development
Our pharmacology document assistance involves an in-depth review of material substances that are critical to the action of the product and includes drug substance Information,…
Review of Adequacy of Safety Data on New or Existing Medical Products
Our safety assessment includes adequacy of the safety data on medical products, including organization’s own safety information on the product, manufacturing, and quality aspects. We…
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…
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…
