Toxicological Assessments Services

  • Health-Based Exposure limits Report (HBEL Report)
    • Permitted Daily Exposure Report (PDE Report)
    • Acceptable Daily Exposure Report (ADE Report)
    • Occupational Exposure Limit Report (OEL Report)
  • Genotoxic Impurity Risk assessment in Pharmaceutical Products
  • Elemental Impurity Risk assessment for Pharmaceutical Products
  • Toxicological Evaluation of Impurities
  • Toxicological Literature Search Report
  • Material Safety Data Sheet (MSDS)

Regulatory Requirements for PDE/ADE Reports

  • EMEA published a guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities in November 2014.
  • The EMEA guideline proposed permitted daily exposure (PDE) values as a basis for establishing appropriate health-based exposure limits.
  • The European Commission (EC) also revised related General GMP Chapters 3 and 5 in January 2015 by updating sections on prevention of cross-contamination; these revisions became effective on 1 March 2015.
  • The EMA guideline effective date was 1 June 2015 for new products and 1 December 2015 for existing products.
  • Therefore, it can be concluded that PDE value derivation is one of the most and critical regulatory (GMP) requirement and mandates the availability of adequate PDE monograph at the manufacturing site. PDEs needs a structured scientific evaluation of all properties and identification of the most critical effect by expert, which is the basis for PDE calculation.

Advantage of Choosing K K Technolegal for ADE/PDE Report

Our Highly Motivated and qualified team of Pharmacologist/Toxicologist with wide variety of expertise and experience in different toxicological spectrum provides high quality documents at affordable cost in time bound manner.

High Quality Documents – Our Expertise

Our Team Comprises of Highly Motivated and qualified Pharmacologist/Toxicologist with wide variety of expertise and experience in different toxicological spectrum. Our Toxicologist is highly qualified and worked with many reputed organization Experience of working on more than 500 molecules for ADE/PDE evaluation for reputed pharmaceutical.

Cost effective Solution

We are offering ADE/PDE report at very competitive cost effective prise. We have data base of more than 500 API for different pharmaceutical dosage form and quick turnaround time for new report.

Time Bound Delivery

We understand organization priority and provide documents delivery at committed timelines. Our shorter turnaround time for new ADE/PDE report ensure timely delivery as per requirement

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