Sterility Assurance & Aseptic Processing •
QC, Microbiology & Analytical

Sterility Assurance & CCS

• Design & implementation of contamination control strategies
• Media fills & aseptic process simulation (APS)
• Operator training, gowning & aseptic technique
• Gap analyses to meet FDA & EU Annex 1 expectations

Aseptic Operations & Tech Transfer

• Process design & scale‑up for sterile injectables (liquid, lyophilized, biologics)
• Manufacturing science & technology (MSAT) support
• Facility & equipment readiness (isolators/RABS)
• Shop‑floor coaching & turnaround of underperforming lines

QC Microbiology & Environmental Monitoring

• Design & trend environmental monitoring programs
• Sterility, bioburden & endotoxin testing programs
• Data integrity & lab workflow improvements
• Investigations & CAPA effectiveness

Analytical Sciences (QC Analytical)

• Method development/verification/validation (HPLC/UPLC, GC, UV/Vis, TOC, compendial)
• Lifecycle: phase‑appropriate validation, robustness, DoE & transfer/bridging
• Specifications & stability: ICH Q1 design, trending, and comparability assessments
• Release & stability testing strategies; CTL/CDMO oversight & governance
• OOS/OOT investigations, data integrity and ALCOA+ controls

Inspection Readiness & Training

• Mock FDA/EMA audits & inspection readiness
• 483/Warning Letter remediation & gap closure
• Interactive training for operators & leaders
• Executive briefings & quality governance

Deep Expertise

Our principal consultant has 15 years of hands‑on experience running QC Microbiology & Analytical labs, launching sterile manufacturing lines and turning around struggling QA programs. We understand your challenges because we've solved them.

Boutique Attention

You're not just another client. We provide big‑firm insight with the flexibility and care of a small practice. Every project is led by an expert—not handed off to juniors—and tailored to your unique needs.

Right‑Sized Solutions

We propose practical, sustainable improvements that balance compliance, speed and cost. From quick diagnostic audits to multi‑site quality system upgrades, we'll work with you to define a scope that makes sense.

Blog & Insights

Our blog features in‑depth articles on sterility assurance, aseptic trends and practical tips. Recent posts include:

• Top Sterility Assurance Audit Findings & How to Avoid Them
• Understanding the EU Annex 1 Revision
• Case Study: Turning Around a Troubled EM Program

Read more articles

Free Sterility Assurance Checklist

Download our checklist to assess your current sterility program against regulatory expectations and industry best practices. It's a great starting point for internal audits or preparing for an upcoming inspection.

We'll send you the checklist and add you to our newsletter so you receive periodic insights. You can unsubscribe at any time.