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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!
How to Manage a Cross-Functional eCTD Submission Team
For small pharma or biotech companies looking to submit their first big application, whether it’s an IND, NDA or BLA, it’s important to...
Jan 153 min read
How to Apply for a Pre-Assigned Application Number
If you're ready to start submitting eCTD applications at the Pre-IND or IND stage -- or even getting ready to submit your NDA or BLA,...
Nov 15, 20243 min read
Navigating Pre-IND Submissions: A Guide for Small and Start-Up Pharma Companies
Preparing to submit an Investigational New Drug (IND) application is a critical step for small and start-up pharmaceutical companies...
Nov 6, 20243 min read
Passing the Mark: The Three Different Levels of FDA Validation Errors
Understanding the differences between low, medium, and high validation errors in the FDA’s eCTD (electronic Common Technical Document)...
Oct 18, 20243 min read
Become a Submission Readiness Genius: How to Create FDA Compliant PDFs
Creating an FDA-compliant PDF document for regulatory submission is a critical step in ensuring that your submission is acceptable for...
Oct 11, 20244 min read
Streamline Your Time-Consuming Marketing Application Tasks
For biotech, pharma, and life sciences start-ups, preparing a marketing application can be a daunting, resource-intensive process....
Sep 30, 20242 min read
Is It Time to Break Up with Your CRO? 4 Telltale Signs
In the complex world of pharmaceutical development, your relationship with your Contract Research Organization (CRO) can make or break...
Aug 21, 20242 min read
What is a US Agent, and How Do I Know if I Need One?
Navigating the regulatory landscape of the U.S. pharmaceutical market can be complex, especially for foreign manufacturers looking to...
Aug 16, 20242 min read
Dear Ops Team in the Cubicle Next Door: How Do We Avoid a Refuse to File When Submitting an NDA/BLA to the FDA?
After working for years to bring a drug to market, not to mention grinding the last several months preparing your NDA or BLA application,...
Jul 31, 20244 min read
Dear Ops Team in the Cubicle Next Door: How Do We Avoid a Clinical Hold When Submitting an IND to the FDA?
Submitting an Investigational New Drug (IND) application to the FDA is a critical step in the development of new therapies. However, one...
Jul 15, 20243 min read
Who's On Your Team? Roles & Responsibilities on Your Operations Team
It's easy to underestimate what it takes to get an IND application out the door. It's not enough to have a great drug candidate -- you...
Jun 21, 20243 min read
Ask a Regulatory Publishing Expert: Understanding FDA's Module 1 Metadata
Let's be honest — sometimes FDA guidance documents can be clear as, well, mud. And one of the quickest ways to find yourself a technical...
May 31, 20244 min read
Streamline Success: Transferring Obligations to CROs
In the ever-evolving landscape of drug development, efficiency, innovation, and cost-effectiveness stand as pillars of success. As...
May 20, 20243 min read
Designing Effective SOPs for Pharma Biotech, and Life Sciences Companies
In the realm of the pharmaceutical industry, where precision and adherence to regulatory standards are paramount, Standard Operating...
May 10, 20242 min read
Strategies for Submitting a Successful IND Application to the FDA
Introduction The submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) is a critical...
Apr 30, 20243 min read
The Importance of Maintaining Source Documents Throughout the Regulatory Submission Process
In the pharmaceutical industry, precision and accuracy are paramount, especially when it comes to regulatory submissions. Every piece of...
Apr 24, 20243 min read
Mastering the Pre-IND Meeting: A Guide to Success with the FDA
Introduction Embarking on the journey to bring a new pharmaceutical product to market is an exciting yet complex endeavor. One crucial...
Apr 17, 20243 min read
Streamlining Regulatory Processes: Converting IMPD to eCTD
Efficient regulatory submissions are pivotal in the pharmaceutical industry's journey from development to market access. In this guide,...
Apr 9, 20242 min read
A SWOT Analysis Template for Pharma, Biotech, and Life Sciences Companies: A Comprehensive Guide
In the dynamic and ever-evolving landscape of pharmaceuticals, biotechnology, and life sciences, strategic planning is paramount for...
Apr 5, 20243 min read
Navigating the Artificial Intelligence Frontier: Pros and Cons of AI for Pharma, Biotech, and Life Sciences Start-ups
Introduction In the fast-evolving landscape of pharmaceuticals, biotechnology, and life sciences, the integration of artificial...
Mar 26, 20243 min read
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