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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
Discovery Sciences
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
Strategy & Programs
Mergers & Acquisition
Quality & Compliance
Quality Management Systems
Control Documentation
Quality Operational Support
Quality Assurance
Audits
Technical Operations
Lab, Manufacturing, GMP Facilities Readiness
Technical Project Management
Technical Facilities Services
Careers
US Careers
India Careers
Medical Writing Fellowship
Resources
White Papers
Articles
Case Studies
Infographics
Webinars
Events
Posters
Media
Press Releases
Media Hits
Publications
Contact Us
Contact Us
Category:
Blog
Overview of FDA Expedited Development and Approval Programs for Serious Conditions
May 4, 2022
May 4, 2022 | Nathaniel DiTommaso, MS, Regulatory Affairs Manager In May of 2014 and February of 2019, the FDA…
The Push for Patient-Focused Drug Development
January 10, 2022
January 10, 2022 | Julia DiFiore, PhD | Clinical Research Scientist Many of us involved with drug development derive a…
Keep ’em Coming: An Overview of IND Updates
June 2, 2020
June 2, 2020 | Kathryn Tworkoski, PhD, RAC | Principal Clinical Research Scientist In the past, we’ve written blog posts…
From Benchtop to Desktop: 8 Transferable Skills Learned in the Lab that Apply to Medical Writing
October 30, 2019
October 30, 2019 | Brandi Schuster, PhD, Clinical Research Scientist | Medical Writing Services So you’ve decided to begin a…
Statistics in Harmony: The Role of Estimands in Regulatory Writing
February 25, 2019
February 25, 2019 | Cheryl Ainslie, PhD, Clinical Research Scientist II | Regulatory Affairs Services In a previous post, I…
Current Topics in Orphan Drug Development
December 14, 2018
December 14, 2018 | Kathryn Tworkoski, PhD, RAC, Senior Clinical Research Scientist │ Regulatory Affairs, Medical Writing, Drug Development Consulting Long-time readers…
The Why, What, When, Who, and How of Quality Control (QC) of Medical Writing Deliverables
May 15, 2018
May 15, 2018 | Nancy Gasper-Smith, PhD, RAC, Consultant, Medical Writing and Submissions Management and Head of Quality Control │…
Ready to Submit Your Initial IND?
April 20, 2018
April 20, 2018 | Kasturi Puranam, PhD | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting I hope…
Before you file your IND…
March 14, 2018
March 14, 2018 | Preeti Chugha, PhD, RAC | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting You’ve…
The Ins and Outs of INDs
February 16, 2018
February 16, 2018 | Kathryn Tworkoski, PhD, RAC | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting Introducing…
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