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PDE Report

Bioexcel Medical Device Research Organization Offer

PDE Report

Experienced & Certified ERT / DABT Toxicologist for PDE Reports & Review.

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?

  • PDE report are report are prepared by qualified toxicologist team & reports are reviewed & Approved by certified DABT (Diplomate American Board of Toxicology) & ERT (European Registered Toxicologist)team work according to client specific template deliver report within short time.
  • Quality control team check from documentation preparation till sign- off.
  • Globally deliver more than +3000 EMA compliance PDE/ADE reports +500 OEL reports & +900 combined PDE/OEL reports
  • Our all reports calculation compliance with EMA/CHMP/CVMP/SWP/169430/2012
  • All reports will be completed as per clients timeline
  • We can work according to client- specific templates & requirements in shortest timeline.
  • Bioexcel work for Pharmaceuticals, Cosmetics, Medical Devices, Food, Nutraceuticals and consumer products.
Help & FAQ

Frequently Asked Questions

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.