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

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

doctors having a meeting

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

Related Services

3D cell and dna diagram

Learn more about Pharmaron’s Biologics & Cell and Gene Therapy services

From discovery to CDMO services

Scientist and DNA strand concept

Learn more about Pharmaron’s integrated Drug Discovery and Development services

Pharmaron offers broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across small molecules, biologics and CGT products.