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Who We Are
Who We Are
Why Choose Us
Our Team
Executive Leadership
Advisory Board
Board of Directors
Bio Book
What We Do
Pharmaceutical Development
CMC Development
CMC Consulting
Drug Development Consulting
Scientific Thought Leadership/Strategy
CDMO Selection
Scientific Technical Writing
Clinical Supply Management
CMC Project Management
Regulatory Strategy and Submissions
Regulatory Consulting (End-to-End Strategy)
General Regulatory Strategy
Regulatory CMC
Non-Clinical/Clinical Strategy
Global Submission Support
IND/CTA and BLA/NDA Strategy, Submissions & Management Services
CMC Technical Writing & Electronic Publishing
Functional Outsourcing Partnerships
Global Post Approval
Product Lifecycle Management
Execution Ready and Outsourcing Team
Medical Writing
Clinical Regulatory Medical Writing
QC Services
Quality & Compliance
Quality Management Systems
Control Documentation
Quality Operational Support
Quality Assurance
Audits
Careers
US Careers
India Careers
Medical Writing Fellowship
Resources
White Papers
Articles
Case Studies
Infographics
Webinars
Events
Media
Press Releases
Media Hits
Publications
Contact Us
Who We Are
Who We Are
Why Choose Us
Our Team
Executive Leadership
Advisory Board
Board of Directors
Bio Book
What We Do
Pharmaceutical Development
CMC Development
CMC Consulting
Drug Development Consulting
Scientific Thought Leadership/Strategy
CDMO Selection
Scientific Technical Writing
Clinical Supply Management
CMC Project Management
Regulatory Strategy and Submissions
Regulatory Consulting (End-to-End Strategy)
General Regulatory Strategy
Regulatory CMC
Non-Clinical/Clinical Strategy
Global Submission Support
IND/CTA and BLA/NDA Strategy, Submissions & Management Services
CMC Technical Writing & Electronic Publishing
Functional Outsourcing Partnerships
Global Post Approval
Product Lifecycle Management
Execution Ready and Outsourcing Team
Medical Writing
Clinical Regulatory Medical Writing
QC Services
Quality & Compliance
Quality Management Systems
Control Documentation
Quality Operational Support
Quality Assurance
Audits
Careers
US Careers
India Careers
Medical Writing Fellowship
Resources
White Papers
Articles
Case Studies
Infographics
Webinars
Events
Media
Press Releases
Media Hits
Publications
Contact Us
Contact Us
Advisory Board
Dimitris Agrafiotis, PhD
Former CIO of the Novartis Institutes for Biomedical Research
Ferdinando Aspesi, PhD
Former Global Head Quality, Aventis/Wyeth Pharmaceuticals
Mike Dyszel
R&D Project Excellence Lead, CSL Behring
Ken Fiorelli, PhD
Former President Compass Biopharma Consulting, Esperion Therapeutics
Corinna Fiorotti, PhD
Chief Commercial Officer at Immunologix Laboratories
Mark Glickman
Former Co-CEO and Chief Business Officer, TherapeuticsMD
Brian Howell
SVP, Global Head of Strategic Partners, Avantor
Arno Kromminga, PhD
Senior Director Scientific and Regulatory Advisory, BioNTech SE
Maggie Pax
Former VP, Strategy & Innovation, Thermo Fisher Scientific