Bench To Batch.An Innovative Regulatory Science Group division

KNOWLEDGE THAT MOVES YOU FORWARD

The CMC field notes.

Practical perspectives at the intersection of manufacturing and regulatory science.

GOOD REGULATORY PRACTICES · 01

Good Regulatory Practices #1: Building Your IND with the End in Mind

Dr. Leona Saunders, IRSG

Build an IND strategy that supports your entire development program, from first dosing to approval.

Good Regulatory Practices · 6 min read

GOOD REGULATORY PRACTICES · 02

Good Regulatory Practices #2: Understanding How FDA Reviews Your IND

Dr. Leona Saunders, IRSG

Understand FDA review priorities and communicate more effectively with your review division.

Good Regulatory Practices · 7 min read

GOOD REGULATORY PRACTICES · 03

Good Regulatory Practices #3: What FDA's Quality Reviewers Are Really Looking For

Dr. Leona Saunders, IRSG

Explore purity, potency, stability and sterility through the lens of FDA’s quality reviewers.

Good Regulatory Practices · 9 min read

GOOD REGULATORY PRACTICES · 04

Good Regulatory Practices #4: Building the Bridge from Animal Studies to First-in-Human Trials

Dr. Leona Saunders, IRSG

Connect nonclinical evidence, species selection and dose escalation to a safe first-in-human plan.

Good Regulatory Practices · 8 min read
Small-scale bioreactor equipment in a cleanroom

MANUFACTURING INSIGHT

The small-batch advantage: single-use micro-suites

A more agile approach to first-in-human manufacturing.

Insight · 5 min read

CMC & REGULATORY

Five CMC bottlenecks to resolve before your IND

Practical considerations for a smoother clinical transition.

Planning guide · 7 min read

PHASE 1 READINESS

Right-sizing cGMP for first-in-human batches

What phase-appropriate quality really means in practice.

Technical brief · 6 min read

YOUR NEXT MILESTONE STARTS HERE.

Let’s bridge the gap
between your science and your first patient.

Manufacturing and regulatory strategy. One connected conversation.

(617) 447-2400Holbrook, MA