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.