top of page
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!
📌 Top FDA News Developments in 2025 Impacting Small Biotech & Pharma Startups
2025 has been a rollercoaster year for the FDA , with leadership turnover, shifting guidance, and increasing pressure on biopharma firms...
Aug 63 min read
🧠 AI Tools for Biotech? Here Are the Questions You Need to Ask Your Vendor About FDA Guidance Compliance
Because "powered by AI" means nothing if it's not also grounded in regulatory reality. As more and more vendors offer AI-powered tools...
Jul 303 min read
AI in Regulatory Writing: Powerful Ally or Risky Shortcut ?
Here’s what early-stage biotech and pharma teams should know before using AI to help write study reports, CMC docs, or regulatory...
Jul 234 min read
What Is 21 CFR Part 11 Compliance—and When Do You Need It?
If you’re working in biotech, pharma, or medical devices, chances are you’ve heard of 21 CFR Part 11 —but many small or growing teams...
Jul 152 min read
How Start-Up Biotechs Can Actually Use the FDA’s Published Complete Response Letters (CRLs)
💡 Smart ways to learn from other sponsors’ stumbles In a move being hailed as a step toward “radical transparency,” the FDA has started...
Jul 113 min read
How Start-Up Biotechs Can Set Themselves Up for IND Success
You’ve got promising preclinical data and a lead candidate with real potential—but before you can begin clinical trials in the U.S., you...
Jul 25 min read
IT Audit Trails: What They Are and Why They Matter in FDA Submissions
If you’re a lean biotech or pharma start-up prepping for your first FDA submission , chances are you’re focused on the science, the data,...
Jun 253 min read
What Kind of IT Infrastructure Does a Pre-IND Biotech Really Need?
If your biotech or pharma start-up is aiming to file its first IND within the next 6 to 12 months, you're probably swimming in scientific...
Jun 173 min read
How to Prepare for eCTD Submissions Without Buying the Software Yet
If your biotech or pharma start-up is preparing to submit its first IND to the FDA, you've probably heard about the electronic Common...
Jun 134 min read
The Hidden IT Risks That Can Derail Your First FDA Submission (and How to Avoid Them)
If you're a lean biotech or pharma start-up racing toward your first IND submission, you're probably laser-focused on the science. But...
Jun 63 min read
5 Signs You’re at Risk for a Delayed Submission
When you're deep in the trenches of preparing an IND or NDA, it can be hard to know if you're on track — or heading for trouble. For...
May 202 min read
Will Your BIMO Package Be a Rate-Limiting Factor?
If you're preparing a marketing application for FDA review—whether a New Drug Application (NDA), Biologics License Application (BLA), or...
May 133 min read
Common Submission Gaps and Risks That Can Derail Your IND or NDA
You've worked hard to bring your drug to the cusp of an IND or NDA filing. But even strong programs can stumble at the final mile — and...
May 63 min read
How to Perform a Submission Gap Analysis and Submission Risk Assessment For Your IND or NDA
If you're preparing a major FDA submission like an IND, NDA or BLA, you already know it's a monumental milestone. But before you hit...
Apr 293 min read
How Start-Up Biotechs Can Succeed in a Turbulent Market (and How SWOT Can Help)
It’s no secret: the current market landscape is tough for start-up pharma and biotech companies. FDA layoffs are threatening to slow down...
Apr 112 min read
How SOPs, Policies, Work Instructions, and Job Aids Keep Biotech Companies Running Smoothly
When it comes to maintaining compliance, efficiency, and consistency in a small pharma or biotech company, having the right documentation...
Mar 113 min read
Keeping Regulatory Operations on Track During Transitions: Why a Flexible Partner Beats a Temporary Hire
In the fast-moving world of pharma and biotech, transitions are inevitable. Whether due to medical leave, layoffs, or the unexpected...
Mar 52 min read
Top Five Microsoft Word Formatting Tips for Start-Up Biotechs
For many start-up biotech companies, Microsoft Word is the go-to tool for drafting regulatory documents, grant proposals, and internal...
Feb 73 min read
How to Motivate a Cross-Functional eCTD Team in Small or Start-Up Pharma Companies
Big FDA submissions, like an IND or NDA, are high-stakes, high-pressure projects. For small or start-up pharma and biotech companies, the...
Jan 312 min read
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
bottom of page