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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!
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
A Women's History Month Interview with SWOT's Founder & CEO
In honor of Women's History Month, check out this interview with our fabulous female founder & CEO, Carla Y. Griffin! While you're at it,...
Mar 29, 20241 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
Busting the Myth: Why Small Biotech and Pharma Companies Must Comply with FDA Regulations
In the world of biotech and pharma, there exists a persistent myth that small companies operating in these sectors are somehow exempt...
Mar 22, 20243 min read
From Research to Market: Navigating the Transition from Research IND to Commercial IND for FDA Submission
Introduction Bringing a new drug to market is a complex journey that begins with promising research and culminates in regulatory...
Mar 13, 20243 min read
Operations Systems Check for Success
We understand how important operations systems are to achieving success. As Operations Strategy experts and enthusiasts, we're here to...
Mar 11, 20241 min read
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