Pharma

Chemsafe can provide your Company with various Toxicological Assessments, such as (but not limited to):
- PDE Assessment for APIs (EMA/CHMP/SWP/169430/2012/00)
- OEL/OEB/ASL Assessment for all type of molecules (API, Intermediates, Reagents, …)
- E&L (Extractables and Leachables) in pharmaceutical field
- Toxicological assessment of solvents in human drug products (ICH Q3C) and veterinary drug products (VICH GL18)
- Toxicological assessment of Impurities (ICH Q3A, ICH Q3B and ICH M7)
- Toxicological assessment of Elemental Impurities in human drug products (ICH Q3D) and veterinary drug products
- Specific and Tailored Risk Assessments

Environmental Risk Assessment (ERA) for Human Medicinal Products, as for EMEA/CHMP/SWP/4447/00 Corr.2, and Veterinary Medicinal Products, as for VICH GL6 and VICH GL38.
It is mandatory for the dossier for the marketing authorisation to include an Environmental Risk Assessment (ERA). This ERA is based on the use of the product and the physico-chemical, ecotoxicological, and fate properties of its active substance, with the aim of protecting aquatic and terrestrial ecosystems including surface water, groundwater, soil and secondary poisoning - and the microbial community in sewage treatment plants. Chemsafe can evaluate potential risks to the environment arising from the use of the medicinal product.

Chemsafe can provide your Company with various Pharmacological Evaluations, contact us for more information.

Chemsafe can provided your Company with extensively bibliographic search.

While Chemsafe has no internal laboratory, we can assist you during the testing phase thanks to our vast and versatile network and partnerships.

“In silico” is an expression meaning “performed on computer or via computer simulation” in the world of biological experiments. “In silico” models are used to virtually investigate molecular behaviour in order to accelerate and save in-vitro studies. The systems simulate human biology thanks to extensive database (e.i. quantitative SAR (QSAR) methods). Chemsafe provides “in silico” prediction for Toxicology (DEREK Nexus), Genotoxicity (SARAH Nexus), Metabolism (METEOR Nexus) and Degradation Products (ZENETH Nexus). Interpretation of results and Expert Report by our ERTs® (European Registered Toxicologist) can be included in this service.

Full Pre-clinical development: Selection of the Testing Panel, CRO selection, Study Monitoring and Data Assessment.
First-in-human (FIH): selection of the testing panel, CRO selection, Study Monitoring and Data Assessment.

The feasibility study is what Chemsafe proposes at the very first stage of complex projects. The feasibility study is a document that provides a preliminary analysis of your product/ingredient. It allows us to respond efficiently to your requests and provides you with an overall picture of time and cost (project planning and timeframe) to reach your goals. It is made through what we call “data gap analysis”. Over the years, costumers have proven to be satisfied with this kind of service because it is perceived as an open table for discussion. In our experience, a preliminary evaluation allows a better definition of the Regulatory Strategy to follow, preventing wasted time and money.

The data gap analysis is the best way for you and for us to understand whether you have all the necessary to reach your goals. More and more often customers are not sure whether what they have is sufficient and what exactly they need to comply with regulations. The data gap analysis is the key to understand what kind of tests/analysis might be missing or need to be implemented to be compliant with the regulations’ requirements.

Chemsafe support its clients in every steps. We care about your success.

Chemsafe can provide your Company with various services, such as (but not limited to):
- Site Master File
- Temporary Manager for assistance to QP and QA managers
- DMF preparation (e-CTD format) Europe, Canada and USA
- CEP (Certificate of suitability) preparation and submission support
- Plans and report for process validation, cleaning and analytical
- Stability protocols
- SOPs (Standard Operating Procedure)
- Pre-audit GMP and inspection to non-EU manufacturer’s sites in cooperation with ILC Srl

Chemsafe can provide your Company with personalized training courses on the topics you prefer, such as (but not limited to):
- PDE Assessment
- OEL/OEB Assessment
- Introduction to Toxicology and Regulatory Toxicology
- Toxicological Assessment of Impurities
- Environmental Risk Assessment