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.
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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.