5 services
Safety and toxicological assessment
Toxicological assessment, exposure limits, product safety and impurity evaluation
Safety dossiers are prepared with scientific depth. Assessments and reports are prepared by a European Registered Toxicologist (ERT) and Fellow of the Academy of Toxicological Sciences (ATS), based on current FDA, EMA and TITCK guidelines.
5 services
The experienced name behind the reports
Reports are prepared, approved and signed by Prof. Dr. Belma Koçer Gümüşel — a European Registered Toxicologist since 2011 and a Fellow of the Academy of Toxicological Sciences (ATS) since 2024, with 150+ scientific articles in toxicology
- 02.1
Toxicology & post-marketing surveillance
Active-substance-specific toxicological assessment and reporting based on current scientific data, including post-marketing safety studies
- 02.2
PDE / ADE / OEL reports, extractables / leachables studies
Exposure limits for cleaning validation and cross-contamination control; signed by ERT and ATS toxicologists, in Turkish and English
- 02.3
Impurity assessment
Toxicological evaluation and reporting of impurities, including nitrosamine and genotoxic impurities
- 02.4
Safety Data Sheet (SDS) preparation and extractables/leachables studies
Preparation and updating of Safety Data Sheets in line with applicable regulations, and extractables/leachables studies
- 02.5
Cosmetic Product Safety Report (CPSR)
Safety assessment under the Turkish Cosmetics Regulation, Product Information File (PIF), cosmetovigilance and regulatory processes in Türkiye and the USA
Send us your active substance and we will scope the work
If you have a list of active substances, we can offer an accelerated portfolio-based option.
Services
- 01
Product R&D and regulatory affairs
From concept to dossier: scientific planning and a regulatory-compliant submission
- 03
Pricing and market access
We stay with you as clinical and economic value is turned into durable market-access decisions
- 04
Mentor Ar-Ge Academy