The Sugar Water Operations Team Blog
Welcome to The Sugar Water Operations Team Blog, your go-to destination for insightful and engaging content for pharma, biotech and life sciences startups (and beyond). Read on to find helpful tips and strategies from "the operations team in the cubicle next door." With decades of experience, we want to help set you up for success on your drug development and approval journey. Never want to miss a post? Follow us on LinkedIn and sign up for our newsletter too!
The Importance of Regulatory Correspondence Tracking: Best Practices for Pharma Teams
Hidden Fees to Watch For When Working With a CRO
How to Apply for a Pre-Assigned Application Number
Navigating Pre-IND Submissions: A Guide for Small and Start-Up Pharma Companies
The Sugar Water Operations Team: ONE YEAR IN
Passing the Mark: The Three Different Levels of FDA Validation Errors
Become a Submission Readiness Genius: How to Create FDA Compliant PDFs
Streamline Your Time-Consuming Marketing Application Tasks
What You Need to Know About eCTD 4.0
Is It Time to Break Up with Your CRO? 4 Telltale Signs
What is a US Agent, and How Do I Know if I Need One?
Dear Ops Team in the Cubicle Next Door: How Do We Avoid a Refuse to File When Submitting an NDA/BLA to the FDA?
Dear Ops Team in the Cubicle Next Door: How Do We Avoid a Clinical Hold When Submitting an IND to the FDA?
Who's On Your Team? Roles & Responsibilities on Your Operations Team
Ask a Regulatory Publishing Expert: Understanding FDA's Module 1 Metadata
Streamline Success: Transferring Obligations to CROs
Designing Effective SOPs for Pharma Biotech, and Life Sciences Companies
Strategies for Submitting a Successful IND Application to the FDA
The Importance of Maintaining Source Documents Throughout the Regulatory Submission Process
Mastering the Pre-IND Meeting: A Guide to Success with the FDA