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)

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