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Regulatory Dossier Authoring and Specification Justification

A group of professionals participates in a regulatory dossier authoring meeting. The lead speaker addresses the team, surrounded by notebooks and documents, as they discuss compliance and documentation for regulatory submissions. A large screen and conference phone suggest a collaborative and formal setting.

Regulatory Dossier Authoring and Specification Justification Services

Pharmaron has a strong history of regulatory interactions for microbial and mammalian recombinant proteins and viral gene therapy products and have supported with the following:

  • CTA, VHP, JNDA, MAA, BLA, IND and IMPD submissions
  • Pre-Approval inspections
  • Type C, scientific advice, PMDA and Type II (CDE) meetings
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Capabilities

Research Grade, High Quality and GMP Plasmid DNA Manufacturing
Viral Vector Process Development
Product Characterization and QC Analytics
GMP Manufacture and QP Release
Regulatory Dossier Authoring and Specification Justification
Connect with a Scientific Expert
A team discusses regulatory dossier authoring and specification justification around a conference table, with notes and devices in hand.
  • Knowledge of multiple therapeutic areas (e.g. eye care, GI, aesthetics, women’s health, oncology)
  • Assembly of Quality CTD sections, dossier ready documentation and inspection readiness
  • Phase appropriate CMC development planning to meet regulatory expectations
  • Orphan drug designation experience for fast-track development plans
  • Attendance at health authority meetings and regulatory audits including PAI
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