Critical Mass Consulting (CMC) partners with biopharma, biotech, and medical device companies to support product development, scale-up, and commercialization. We specialize in Integrated CQV, facility readiness, digital transformation, and end-to-end commissioning, qualification, and validation support.

Traditional CQV treats commissioning, qualification, and validation as separate steps. Integrated CQV brings these together from the start, aligning engineering, quality, and operations under one plan. This approach reduces rework, accelerates timelines, and provides better documentation for regulators. Clients benefit from faster facility start-up and lower cost of validation.

We work with teams across the product lifecycle, including: emerging biotech and start-ups, mid-size and large biopharma companies, contract development and manufacturing organizations (CDMOs), and medical device and diagnostics firms

Our expertise includes new facility builds and facility expansions, tech transfer between sites or to CDMOs, equipment selection, FAT/SAT, and qualification, process and cleaning validation, data integrity and digital compliance, quality system optimization, and capital project planning and oversight

Yes. Our teams design project plans, CQV strategies, and validation deliverables compliant with FDA (21 CFR Parts 11, 210, 211), EU Annex 11 & Annex 12, and ICH Q7, Q8, Q9, Q10, Q12

We help clients build documentation that withstands audits and inspections.

Absolutely. Many of our clients are resource-constrained early-stage teams preparing for their first facility, first GMP run, or first regulatory submission. We help build scalable systems without unnecessary complexity or cost.

Earlier than most teams expect. Engaging us during concept design or equipment selection prevents costly changes later. Early involvement helps align engineering, quality, and operations so the facility is “right-the-first-time” when you reach qualification and validation.

We provide all three, depending on the project. For commissioning, qualification, and validation activities, we typically deploy on-site teams. For strategy or digital work, hybrid and remote support are common.

You can reach out via our contact page, and we will schedule a short discovery call. We’ll review your goals, timeline, constraints, and key risks to determine the right scope and approach.