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
Unterstützung bei der Zulassung - QiP GmbH

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

Projectmanagement

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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