You have to guarantee the regulatory
compliance of your biomedical research:
- You must adapt to a complex and dynamic
regulatory environment (French Public Health
Code,
Personal Data Protection Law,
"DMOS" Law, etc.)
- You have to keep up with legal,
regulatory news and reference standards
- You have to control your processes and
their compliance with laws, regulations, and
the current reference data (in France,
Europe, United States, etc.)
- You have to anticipate changes and
understand how they will affect your
organization
Do you have the Regulatory Intelligence
and assistance that you need at your
disposal?
"SUN.eVeille Recherche Biomédicale" is a
monthly bulletin (in French) concerning regulatory
intelligence in biomedical research:
- Follow the changes in affected
guidelines: legislation,
regulations and requirements, in France, in
the European community (which does not take
into account the national regulations), and
in the USA, in
particular: French Public Health Code,
ICH recommendations, the Federal Register,
etc.
- Follow up on guidelines you are
indirectly impacted by, such as:
protection of personal data, "DMOS" Law, Good
Manufacturing Practices of Investigational
Medicinal Products, etc.
- Products : medicinal products, medical
device (except FDA).
For you, "SUN.eVeille Recherche
Biomédicale" is:
Regulatory Assistance in biomedical
research
As supplemental information to the
regulatory intelligence bulletin, SUNNIKAN
Consulting provides fixed-rate Regulatory
Assistance in biomedical research:
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