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perf. evaluation - IVDR
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clin. evaluation
MDR - Transition
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PMS - Post-Market-Surveillance
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MDR - Transition
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Assistance with approval
Medicines, etc. Ä.
Management of multi-center clinical trials and eSubmissions
Creation and maintenance of approval files, e.g. B. Investigational Medicinal Product Dossier (IMPD),
CTD dossier (Common Technical Document), etc.
Regulatory compliance (compliance with applicable legislation), including a. GMP (Good Manufacturing Practice)
Administrative affairs / regulatory affairs (ethics committees, higher federal authorities, notified bodies, etc.)
Novel foods:
FDA GRAS (Generally Recognized As Safe) assessment procedure
EFSA (European Food Safety Authority) procedure for the marketing authorization according to EU regulation 2015/2283
ORGANIZATION, IMPLEMENTATION AND FOLLOW-UP OF TRAINING AND TRAINING MEASURES IN PARTICULAR:
FDA GRAS
Generally Recognized As Safe
EFSA
European Food Safety Authority
GCP
Good clinical practice
GMP
Good manufacturing practice
GLP
Good laboratory practice
GDP
good documentation practice
Medical devices
Anti-corruption
privacy
and more
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Services at a glance
Medicinal product, in particular phase I First in Man und Advanced Therapy Medicinal Products (ATMP, z.B. Stammzellen)
Medical devices of all classes and in-vitro diagnostics
Other forms of diagnosis and therapy
Post-marketing studies and application observations
for children, young people and adults
Human Factor Studies
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IVDR (EU-VO 2017/746) Transition
MDR (Medizinprodukte) Transition
Audits
clinical evaluation
Independent performance evaluation
Riskmanagement
Validation
Qualitymanagement - System
Qualitymanagement - Workshops
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