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

We have had nothing but an excellent experience with Onorach. We are impressed with their flexibility and proactive approach. The attitude demonstrated by the team was nothing short of 100% professional in every way and they were always prepared to go the extra mile.
A UK Client

 

Join Our MAILING LIST