- Permitted daily exposure reports for Active substances (PDE Reports/ HBEL) as per EMA/CHMP/ CVMP/ SWP/169430/2012 (>600 PDE reports provided so far)
- Elemental impurity risk assessment of Active substance or Finished product as per ICH Q3D (>100 Elemental impurity risk assessments completed)
- Nitrosamine risk assessment of Active substance or Finished product as per EMA / MHRA Guidance (> 125 Nitrosamine risk assessments completed)
- Genotoxic impurity assessment of Active substance or Finished product as per ICHM8 (>20 Genotoxic impurity risk assessments completed)
- Toxicological safety determination of unknown Impurity as per ICHQ Q3B (>10 molecules successfully approved with authority)
- Module 2:Non-clinical dossier review and approval(> 25 Module 2: Non-clinical dossier reviewed and approved)
- Acted as Subject Matter experts for Toxicological assessment during MHRA audits and audits were successfully (7 times since Mar2015)
- Cosmetic Product Safety Report (CPSR) for different type of products (>50CPSR completed)
- Cross Contamination control strategy for the site (>10CCCS completed)
Toxicology
Mr Jaimin Patel has Master of Science in Toxicology degree from University of East London, UK, and an active member of British Toxicology Society. He has over 13years of pharmaceutical industry experience in Toxicology assessments including Permitted daily exposure report (PDE report) / Health based exposure limit (HBEL report). .
He is approved as Toxicologist Expert in United Kingdom register of Toxicology (UKRT) and European Register of Toxicology (ERT).
We can offer wide range of Toxicological services via Certified Toxicologist such as :
