For all Manufacture company which shared their facilities for different medicinal products should implement European Medicines Agency (EMA) guidelines on setting health-based exposure limits (HBEL) for use in risk identification (toxicological risk). The derivation of such threshold value (e.g. Permitted daily exposure or threshold of toxicological concern (TTC) should be the result of structured scientific evaluation of all available pharmacological & toxicological data including both non- clinical & clinical data.
Why Bioexcel Lifesciences for Health based exposure limit report?
YES, Toxicological or Pharmacological data on which HBELs calculation relies, require periodical re-assessment throughout a product’s life cycle.
Experienced toxicologist/ Pharmacologist having experience in determination of health-based exposure limits such as occupational exposure level( OEL ) or Permitted Daily Exposure (PDE).
DABT (Diplomate American Board of Toxicology) and ERT (European Registered Toxicologist) certified
Permitted Daily Exposure limits or Allowable daily exposure (PDE or ADE) , Occupational Exposure level (OEL), Biological Evaluation Report for Medical Device (BER) for Pharmaceuticals, Cosmetics, Medical Devices, Food, Nutraceuticals and consumer products.
YES, Regulatory reviewed taking account of any new relevant data.
TO BREAK THE BARRIERS OF TRADITIONAL CLINICAL INVESTIGATION FOR MEDICAL DEVICE INDUSTRY
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