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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
Quality & Compliance
Quality Management Systems
Control Documentation
Quality Operational Support
Quality Assurance
Audits
Strategy & Programs
Mergers & Acquisition
Careers
US Careers
India Careers
Medical Writing Fellowship
Resources
White Papers
Articles
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Events
Posters
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Contact Us
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Category:
Blog
Why are Biologics Drugs Different
July 1, 2024
What is a biologic drug and how does it differ from a traditional small molecule drug? Biologic drugs have increasingly…
Why Hire an Experienced CMC Consultant for Your Early Phase Studies
July 1, 2024
The simple answer is you save money, time and get an exciting new drug to the clinic for patients. What…
Understanding the Nuances of a Clinical Study Protocol
June 11, 2024
One of the first recommendations that I received as an entry-level medical writer when I started writing clinical study protocols…
Exploring Risk-Based Approaches to Raw Material Testing in Pharmaceutical Manufacturing
May 23, 2024
In the rapidly evolving pharmaceutical industry, the quality and safety of drug substances and products hinge significantly on the integrity…
Potency Assurance for Cellular and Gene Therapy Products
April 16, 2024
One of the many challenges around developing cell and gene therapy products is establishing representative potency methods. In 2011, the…
Conducting Clinical Trials in Australia
April 5, 2024
05 Apr 2024 | Nate DiTommaso, Rachel Capone, Renee Boerner Have you ever wondered why some companies choose to do…
Syner-G Solutions To Navigating Medical Writing From Home
March 28, 2024
28 March 2024 | Olivia Rivera, PhD and Yael-Natalie H Escobar, PhD When COVID-19 shut down workplaces, remote work became…
Shortening the Timeline: A Medical Writer’s Guide to Success
March 25, 2024
25 Mar 2024 │ Christina (Chrissy) Williams, PhD, RAC, Sr Director │ Medical Writing Services How can we shorten…
Writing with Style: Why styles are important in medical writing
March 11, 2024
05 Mar 2024 │ Euan Griffiths, Senior Quality Control Specialist │ Medical Writing Services When we think of medical…
Prescription for Success: Streamlining Meetings to Craft Compelling Regulatory Documents
February 29, 2024
February 29, 2024 | Evan DuBose, PhD and Kelsey Gray, PhD – Clinical Research Scientists | Medical Writing Services …
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