Health Based Exposure limits (PDE/ADE/OEL/OEB/ADI)
Expertise in deriving health-based exposure limits (HBELs) and performing scientifically supportable risk assessment to establish Permitted Daily Exposure (PDE)/ Acceptable Daily Exposure (ADE), Occupational Exposure Limits (OELs) for Active pharmaceutical ingredients (APIs) and contaminants (detergents, intermediates etc.) in multi-purpose pharmaceutical and chemical plant manufacturing operations.
Assigning of APIs/Chemicals to Occupational Exposure Bands (OEBs) as per OSHA/NIOSH standards
Applicable regulations: Annex 15 of the EU GMP Guide and EMA “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” (EMA/CHMP/ CVMP/ SWP/169430/2012).
Delivered 350+ EMA / ANVISA compliant PDE/ADE reports and 50+ combined PDE/OEL reports
Impurities qualification and to derive safety based limits for the control of impurities in drug substances (ICH Q3A R2) and Drug Products (ICH Q3B R2)
Safety risk assessment of residual solvents (ICH Q3C R8), and elemental impurities (ICH Q3D R1)
DNA reactive (mutagenic) impurities risk assessment to comply with ICH M7(R1) guideline e.g. Nitrosamines risk assessment,
Risk Assessment of impurities in oncology products (ICH S9)
Successfully delivered 25+ Impurity (DNA reactive/mutagenic) risk assessments to comply with ICH M(7) guideline.
Drug Master File (DMF) / CEP Compliance services
Type-2 USDMF, ASMF(EDMF), Certification of Suitability (CEP) and ROW DMF - compilation, review and eCTD upload of DMF
Support Registration of API in China
Support for responding to the authorities for any query on DMF
Support for Regulatory compliance (including change management) activities
eCTD support for DMF submissions for regulated markets
Nitrosamine risk assessment document drafting
Genotoxicity risk assessment document drafting
Perform and prepared structural characterization report for APIs and impurities as per USFDA requirements
Compilation, review and eCTD upload of Type-III DMF for Packaging material
Type-II DMF for veterinary APIs
Technical packages
Drug product related services
Filling of drug product variation in EU market for quality and labelling changes
API vendor management activities, this includes review of quality of DMF and API submissions and other support including change management
The materials used to fabricate container closure systems (CCS), medical devices, and processing equipment are often polymers (such as plastic or elastomers), metal or glass. These materials are prone to leaching unwanted chemicals into the product formulations when they are used in applications such as manufacturing, drug delivery devices, or packaging. Depending on the toxicity of the chemicals, leachables can present two-fold risks: 1) significant safety risk to the patient and 2) by reducing the efficacy of the drug. In order to manage safety concerns and ensure high degree of compliance, we are performing risk assessment of Extractables & Leachables (E&L) in line with region specific guidelines (US FDA, EMA, PQRI, PDA).
