Regulatory Services

 

Regulatory Expertise

  • IMPDs (Investigational Medicinal Product Dossier)
  • PSFs (Product Specification Files)
  • Pre-INDs (meeting request & meeting packages)
  • INDs (investigational New Drug Application)
  • MAAs (Marketing Authorisation Applications)
  • DMFs (Drug Master Files)
  • Compounds: small molecules, peptides, new chemical entities/dosage forms of existing drugs
  • Routes of administration: injection, orals, sub-mucosal, topical
  • Medical Device Design Dossiers and Technical Files (Class I – Class III)

Product Development

  • Regulatory and Product Development Strategy
  • Supplier Management
  • Validation
  • PSFs (Product Specification Files)
  • Technical Transfer

Preparation of Regulatory Submissions

  • IMPDs (Investigational Medicinal Product Dossier)
  • Pre-INDs (meeting request & meeting packages)
  • INDs (Investigational New Drug Application)
  • MAAs (Marketing Authorisation Applications)
  • DMFs (Drug Master Files)


Contact us for more information... 

Client Testimonial

Onorach provided excellent monitoring and site management activities for a large, retrospective cancer diagnostic trial in Europe. Onorach's representative is a quick learner, pays excellent attention to detail and is a pleasure to work with. A truly well experienced clinical research professional. Top qualities: Personable, High Integrity, Creative.
Joe Bigley, VP of Clinical Affairs at MDxHealth

 

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