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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
Contact Us
Category:
Blog
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…
Publishing an eCTD Clinical Study Report: ICH E3
August 15, 2017
August 15, 2017 | B J. Witkin, Senior Manager | Regulatory Operations Because IMPACT writes and publishes so many CSRs,…
What Skills Do You Need to Be a Good Regulatory Medical Writer?
August 25, 2016
August 25, 2016 | Kim Nice, PhD, Associate Director, Medical Writing and Submissions Management | Medical Writing Services In previous…
Record Numbers of FDA‑Approved Drugs: Recent Trends
March 10, 2016
March 10, 2016 | Kathryn Tworkoski, PhD, Clinical Research Scientist | Regulatory Affairs, Medical Writing Services, Drug Development Consulting Everyone…
Planning Your NDA or BLA Submission: It’s More Than a Gantt Chart!
February 25, 2016
February 25, 2016 | Tim Garver, PhD, Executive VP and Chief Operating Officer | Medical Writing Services You’re finally there!…
Top Two Things I Learned at DIA RSIDM
February 18, 2016
February 18, 2016 | B J. Witkin, Senior Manager | Regulatory Operations I recently attended the DIA’s Regulatory Submissions, Information,…
Formal Meetings with FDA for Biosimilar Products
February 10, 2016
February 10, 2016 | Chip Carnathan, PhD, RAC, Director Regulatory Affairs | Regulatory Affairs, Drug Development Consulting Yeah, yeah, we…
How to Make Publishing Clinical Summaries Easier
February 4, 2016
February 4, 2016 | BJ Witkin, Senior Manager | Regulatory Operations One of the biggest challenges of publishing an NDA,…
Direct-to-Consumer Advertising of Prescription Drugs
August 20, 2015
August 20, 2015 | Mark Cierpial, PhD, RAC, Chief Executive Officer | Regulatory Affairs We’ve all seen or heard them…
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