CLEANING VALIDATION AND OCCUPATIONAL HEALTH
Permitted Daily Exposure (PDE) / Acceptable Daily Exposure (ADE)Occupational Exposure Limit (OEL)Occupational Exposure Banding (OEB) / Occupational HealthCategorization (OHC)Maximum Allowable Carryover(MACO)Impurities Qualification as per ICHQ3A / ICHQ3BElemental impurity assessment as per ICHQ3DImpurity Assessment for residual solvent as per ICHQ3CGenotoxic Assessment of Impurities (In-silico / Literature) as per ICHM7Nitrosamine risk assessment / Cohort of Concerns as per USFDA & EMEAExcipient evaluation and justification for the proposed limitExtractables and Leachables (E&L) toxicology assessment Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) as per EU MDR 2017/745 & ISO 10993Toxicological Risk Assessment (TRA) as per ISO 10993-17Gap assessment as per EU MDR 2017/745 & ISO 10993Designing of biocompatibility studies as per ISO 10993 & ISO 18562Risk Management Plan (RMP) as per ISO 14971Materials qualification / BiocompatibilityStudy placement, monitoring, report preparation/review Exposure calculations and toxicological write-ups for individual INCICosmetic Product Safety Report (CPSR) as per SCCS & EU RegulationsProduct Information File (PIF) as per SCCS & EU regulationsExposure calculations for INCIFragrance and flavours assessment ECOTOXICOLOGICAL AND ENVIRONMENTAL RISK ASSESSMENT
Environmental Risk Assessment (ERA) for pharmaceuticals, chemicals, agri and consumer productsREACH compliance support- classification, labelling and packaging (CLP) of substances and mixtures as per EU regulations 1907/2006Globally harmonized system (GHS) classificationSafety Data Sheet (SDS) or Material Safety Data Sheet (MSDS) authoring AGRI AND CONSUMER PRODUCTS
Pesticide Risk Assessment / Maximum Residual Levels (MRL) as per USEPAFood contact materials / food additive evaluationToxicological evaluation of consumer productsExposure assessment of consumer productsGenerally recognized as safe (GRAS) ReportToxicological Risk Assessment for toys as per EU Directive 2009/48/ECLiterature Search and data miningIn-Silico predictions using Derek & Sarah, Case Ultra, OECD QSAR Tool Box and EPI SuitLiterature search and data miningRecommendation & monitoring of preclinical and analytical CROsTox Profile CTD / eCTD dossiers compilationAnnual report compilation: Periodic Safety Update Report (PSUR), Drug Safety Update Report (DSUR), Addendum to Clinical Overview (ACO) and New Drug Application (NDA)Product Information Leaflet (PIL) Compilation of Drug Master File (DMF) - Open & Restricted partGap assessment of dossier submission for generic and innovative products (REACH, USFDA and etc)