Reflector Consulting - Products & Services - Regulatory & Scientific Support

Regulatory & Scientific Support

examples

Calculation of safety limits, e.g.
- Acceptable Intake (AI)
- Derived Minimum Effect Level (DMEL)
- Derived No Effect Level (DNEL)
- Permitted Daily Exposure (PDE)
- Health Based Exposure Level (HBEL)
- Tolerable Contact Level (TCL)
- Tolerable Exposure/Intake (TE/TI)
Prepare toxicology sections in regulatory documents & registration dossiers, e.g.
- Chemical Safety Reports (CSR)
- Investigational New Drugs (IND)
- Investigator’s Brochure (IB)
- Investigational Medicinal Product Dossiers (IMPD)
- International Uniform Chemical Information Database (IUCLID)
- Marketing Authorisation Application (MAA)
- Safety statements including exposure, hazard & risk assessment
Argumentation to Regulatory Authorities
- Questions & Answers on regulatory questions
- Literature search on toxicological data & methods
- Mechanistic & human relevance interpretation
- Compilation of regulatory safety statements
- Argumentation during regulatory discussions
- ...

Regulatory & Scientific Support

process