Our biopharma consulting services

We work on three problems: building a quality system that can scale, carrying the Annex 1 and microbiological depth commercial sterile manufacturers need, and running remediation programs to closure when a regulator is involved. Lean and Six Sigma are how the work gets done here, not a service line. We work with clients in the United States and India. We build the quality systems and SOPs clinical-stage biotechs need to scale, bring deep microbiological expertise and Annex 1 compliance to commercial-stage manufacturers, and lead remediation programs for companies under a consent decree or warning letter.

Every engagement starts with a Rapid Diagnostic

Before we propose a program, we establish what is actually driving the problem. The Rapid Diagnostic is a short, fixed-scope assessment that produces findings, root cause, a prioritized remediation sequence and a resource estimate, delivered in as little as two weeks depending on the scope of the diagnostic. It applies across all six practice areas below, and it is step 02 of how we work.

Our Services

We build the quality systems. We carry the Annex 1 and microbiological depth most generalist firms do not. So when a regulator gets involved, the firm running your remediation program already understands both the systems and the science underneath them. That is why these six lines sit in one firm and not six.

Remediation & Transformation PMO

For companies operating under a consent decree, warning letter, or a major 483.

Governance for commitments made to a regulator and for multi-site transformation programs. We stand up remediation program governance, track every 483 observation and consent decree commitment through to closure with its evidence attached, prioritize the portfolio transparently, and report against tiered KPIs that show whether commitments are converging. Built on a capability framework deployed across a 37-site global network, and handed over rather than made permanent.

Quality System Design & SOP Development

For clinical-stage and newly commercial companies building a quality system for the first time.

End-to-end quality and compliance solutions, from phase-based deployment and system design to SOP simplification, standardization, optimization, and harmonization. Our services also include multi-site QMS integration, electronic batch record and e-QMS deployment, AI governance for GMP operations, data integrity, supplier and vendor quality oversight, and risk-based process improvement.

Annex 1 & Microbiological Compliance

For commercial sterile and aseptic manufacturers in the US and India.

Annex 1-aligned contamination control strategy, environmental monitoring program design, microbiological investigations, and aseptic and sterility root cause analysis. The technical depth most generalist quality firms do not carry — and what our sterile manufacturing clients in the US and India come to us for first.

Inspection Management

For sites facing a pre-approval, surveillance, for-cause or follow-up inspection.

Regulatory audit readiness across Pre-Approval, Surveillance, For-Cause, Follow-Up and Post-Approval inspections. We run mock inspections, prepare the room and the narrative, and build 483 and EU deficiency response strategy. Response strategy ends here; closure governance belongs to the Remediation & Transformation PMO.

Quality Investigations, CAPAs & Change Controls

For quality organizations carrying a deviation backlog or repeat findings.

We specialize in designing robust quality investigation and change control processes, supported by targeted training to build internal capabilities, reduce complaints and improve compliance. Our services include root cause analysis, CAPA effectiveness checks, and predictive trending that anticipates recurrence rather than reporting it after closure.

Operational Excellence & Supply Chain Resilience

For established manufacturers with throughput, cost or supply reliability problems.

Lean Six Sigma deployment, continuous improvement, performance dashboards and COGS analysis, together with end-to-end supply chain mapping, inventory optimization, procurement redesign and Control Tower deployment. Efficiency and supply reliability for established manufacturers. Supply chain detail.