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 adapted quickly to our requirements... ethical approval was dealt with quickly and effectively... with excellent communications maintained throughout. Onorach have been highly effective and I would not hesitate to use their services for future projects.
David Craig, Sales & Marketing Manager. Axis-Shield Diagnostics Ltd

 

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