RegSafe
www.regsafe.se
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Services
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Services offered by RegSafe...
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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
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Risk/Safety assessment and qualification of impurities and/or
degradation products in drug substances and drug products (ICH
Q3A(R2), Q3B(R2), Q3C, M7)
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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
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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
etc
- Cosmetics:
Safety assessment reports of cosmetic ingredients and
products
- Chemicals:
Chemical safety assessment reports
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Solving issues related to cross-contamination during
manufacturing, and preparation of cleaning validation
reports
(health based exposure limits, PDE, shared facilities,
EMA Guidelines)
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Reviewing data in industrial hygiene and preparation of
criteria documents as basis for establishing of
occupational exposure limits (OELs)
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Expert advice for toxicological/safety issues
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Expert opinion
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Expert statements
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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.
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