Offer regulatory, technical and legal expertise in the field of chemical safety and pharma quality and drug development with “key-point” approach and customer care attitude.
Founded in August 2001, ChemSafe offers its clients a combined Scientific, Regulatory and Project Management expertise based on more than 20 years’ experience in the field of chemical safety and pharmaceutical companies support.
ChemSafe operates as a centre of expertise, offering the best option available in terms of science quality, cost, time- effectiveness and compliance with regulatory requirements worldwide. Flexibility is the key of our success.
ChemSafe provides consultancy and project management solutions to chemical, pharmaceutical, petrochemical, cosmetic, biocides and agrochemical companies. Currently we support a total number of 130 customers worldwide.
Due to its long time achieved expertise ChemSafe can monitor outsourced testing programmes for safety assessment of substances, chemical products and pharmaceuticals in highly qualified and selected international testing laboratories in each area of expertise. All testing laboratories are GLP compliant and using OECD methods.
“In vitro” methods and “In silico” QSAR prediction approaches are available too!
A well consolidated network of relationship with the main National Competent Authorities, as well as a good experience with ECHA, EFSA and EMA allows us to offer the best services for dossier submission and post submission liaison.
Regulatory & Legal advice, Data gaps analysis and reliability assessment, Data search.
CUSTOMIZED TESTING PROGRAMME
Cost & time effectiveness
Reduce “in vivo” testing
TESTING PROJECT COORDINATION and MONITORING
CLASSIFICATION & LABELLING
SUBMISSION TO COMPETENT AUTHORITY & DISCUSSION
LIAISON WITH REGULATORY BODIES & DISCUSSION
- OEL/OEB/ASL assessment
- PDE assessment (EMA/CHMP/SWP/169430/2012) for shared facilities including pediatric use and special cases.
- ERA (EMEA/CHMP/SWP/4447/00): Environmental Risk Assessment of medicinal products including testing phases.
- E&L (EXTRACTABLES and LEACHABLES): Toxicological assessment including data search.
- IMPURITIES (ICH M7): evaluation of toxicological and genotoxicological intrisic properties (in silico and testing)
- ELEMENTAL IMPURITIES (ICH Q3D): evaluation of safety profile
- SOLVENTS (ICH Q3C): evaluation of safety profile
- Site Master File
- AIFA notification
- DMF preparation (e-CDT format) Europe, Canada and USA
- Suitability dossier
- Plans and report for process validation, cleaning and analytical
- Stability protocols
- SOPs (Standard Operating Procedures)
- Specific Risk Assessment
- Pre-audit GMP and inspection to non EU manifacturer sites
- Temporary Manager, assistance to QP and QA managers
CANDIDATE PROFILING TO PRE-CLINICAL DEVELOPMENT
1. Candidate profiling: in silico evaluation, CRO selection and study monitoring
2. First into man: selection of testing panel, study monitoring Espert Report
3. Full pre-clinical development: selection of testing panel, study monitoring and Espert Report
Study monitoring and Expert Report by our ERT (European Registered Toxicologist)
identification of testing package, CRO selection, Study Monitoring and Expert Report.
PIF (Product Information File) and PSR (Product Safety Report) preparation, Competent person designation, efficacy and safety studies, data evaluation and administrative management.
17 STAFF PEOPLE READY TO HELP YOU !!