Deep understanding of the European Medicines Agency (EMA) Good Manufacturing Practice (GMP) guidelines to calculate health-based exposure limits
Comprehensive knowledge on calculation/derivation of no-observed-adverse-effect level (NOAEL), no observed effect level (NOEL) and lowest-observed-adverse-effect-level (LOAEL)
Calculation of Permitted Daily Exposure (PDE) for APIs
Calculation/derivation of
Accepted Daily Exposure (ADE)
Threshold of Toxicological Concern (TTC)
The median lethal dose (LD50)
Residual solvents and impurities in PPM
Monitoring levels of the cleaning validation for a huge set of medicinal products from various shared facilities
Access to toxicological literature
Establishing permitted daily exposure (PDE) for solvents and impurities
Support for impurity qualification for solvents (ICH, Q3C) and elemental impurities (ICH, Q3D)
Derivation of PDE for other routes of drug product administration and further qualification of impurities
Streamlined data collection to be incorporated into PDE reporting requirements
Technical and protocol support for cleaning validation
Occupational Safety
Calculating occupational exposure limit (OEL) value (not mandatory for Pharma manufacturing unit, but occupational exposure values (OEVs) are still established by the manufacturing units for pharmaceuticals, in-order to assure safety of workers at work place)
Establishing occupational exposure bands (OEBs)
We at Maven can provide these working procedures with ease
Welcome to Maven, one of the best Regulatory Consultants that is setup by real life working professionals with very rich experience. We at Maven understand the customers pulse and reach their expectations. We are unique and focus on quality is our prime goal. Maven works with any range of company that is looking for quality and in time delivery of services.
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