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What is RegSafe

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What is RegSafe...

RegSafe – Regulatory Safety Sciences, Consultant in Regulatory Toxicology and Risk/Safety Assessment was formed in early 2004 by Lars Wiklund, ERT, Safety Assessor/Senior Toxicologist, who previously was part of Pharmacia World Wide Toxicology/Safety Assessment. Altogether this provides more than 35 years of experience in chemical, pharmaceutical and consumer products safety assessments

RegSafe is offering consultancy services and expertise to a number of customers, and the services include:

Toxicological evaluation and Risk/Safety assessment:
of pharmaceuticals (APIs, excipients), cosmetics (ingredients, final products), industrial and consumer chemicals, food additives, and many other compounds.

Also risk/safety assessment and qualification of impurities and/or degradation products in drug substances and drug products (ICH Q3A, Q3B, Q3C, M7), including in silico analyses, and TTC approaches are performed.

Issues related to cross-contamination and cleaning validation during manufacturing (health based exposure limits, PDE, shared facilities, EMA Guideline 2014), as well as topics associated with industrial hygiene and occupational exposure limits (OELs, criteria documents etc) are also conducted.

RegSafe has an excellent knowledge of information sources in toxicology and risk/safety assessment, e.g. electronic scientific databases, expert group evaluations and risk/safety assessments, and can thus offer searches and quick retrieval of relevant toxicological documentation.

Teaching and Tutorial activities:
Lars Wiklund is frequently requested as a teacher and/or tutor at universities and national and international programmes and courses, e.g. Global Master Programme in Toxicology, Karolinska Institutet.


With this experience RegSafe is offering expertise and businesses related to regulatory toxicology/safety issues such as risk/safety assessments, reports or statements, toxicological advice, expert opinion and other scientific questions.

RegSafe has established effective working relationships with several different organisations ranging from start-up companies, small & medium sized enterprises, small to global pharmaceutical companies, regulatory agencies and universities for a variety of projects.