Sunnikan offers regulatory monitoring and support tools
Regulations are constantly changing and becoming increasingly complex (French public health code, EU regulations, personal data protection laws, GDPR, DMOS law, etc.).
Sunnikan publishes two monthly regulatory monitoring newsletters ('Research With Human Subjects (RWHS)' and 'Genetically-Modified organisms (GMO)') and offers regulatory assistance in clinical research.
'Research With Human Subjects (RWHS)'
Sunnikan offers regulatory assistance and monitoring tools that enable clients to keep up to speed with the latest legislation and regulations as well as recommendations from France, Europe and the United States. This ensures clinical research processes remain compliant with the regulations in force and allow subscribers to plan ahead and understand the implications for their quality assurance systems.
Sunnikan publishes a monthly 'Research With Human Subjects' regulatory monitoring newsletter:
'Genetically-Modified Organism' (GMO)
The scope of Sunnikan's 'Genetically-Modified Organism' (GMO) regulatory monitoring includes specific regulations pertaining to basic research, pre-clinical research (GMO handling, transgenic animals, administering GMOs to animals) and clinical research surrounding GMOs.
The scope of application is essentially restricted to French and EU regulations (EMA, European Commission).
"Safety Observer" (PV FOCUS)
Sunnikan contributes to the pharmacovigilance regulatory monitoring research conducted by PV Focus: www.safetyobserver.com
The monthly newsletter includes a summary of texts and direct links to all new regulations and initiatives that fall within the scope of pharmacovigilance. This includes regulatory texts, draft bills, product notifications, etc.