Start page

What is RegSafe

Personnel at RegSafe

Services offered by RegSafe

Contact RegSafe


Services offered by RegSafe...

  • RegSafe offers consultancy services and expertise for many toxicological/safety issues, including searching and evaluation of toxicological data, safety assessment of pharmaceuticals (APIs, excipients), cosmetics (ingredients, final products), consumer chemicals, food additives and other compounds or products
  • Risk/Safety assessment and qualification of impurities and/or degradation products in drug substances and drug products (ICH Q3A(R2), Q3B(R2), Q3C, M7)
  • Derivation of human exposure threshold values - Threshold of Toxicological Concern (TTC) or default Acceptable Daily Exposure (ADE) values - for substances that have limited or no toxicity data
  •  Regulatory documents
    - Pharmaceuticals:
       Evaluation of preclinical safety data to support clinical
       development programs and final registration, e.g., authoring of
       non-clinical overviews, the toxicology parts of IMPD, IB

    - Cosmetics:
    Safety assessment reports of cosmetic ingredients and products
    - Chemicals:
       Chemical safety assessment reports
  • Solving issues related to cross-contamination during manufacturing, and preparation of cleaning validation reports (health based exposure limits, PDE, shared facilities, EMA Guidelines)
  • Reviewing data in industrial hygiene and preparation of criteria documents as basis for establishing of occupational exposure limits (OELs)
  • Expert advice for toxicological/safety issues
  • Expert opinion
  • Expert statements
  • Understanding and responding to regulatory questions

The services are tailored according to the specific request and situations.

Education and Training
Lars Wiklund is highly involved as a teacher/tutor at international programmes and courses within several fields of Toxicology and Risk/Safety Assessment.