Altabrisa Group — Industries

Cell & Gene Therapy Consulting for GMP-Regulated Developers

Cell and gene therapy consulting from IND through commercial licensure. We build the quality systems, manage inspection readiness, and resolve the compliance gaps that advanced therapy developers can’t afford to ignore.

Autologous & Allogeneic
Viral Vector Manufacturing
IND / BLA Readiness
FDA & EMA Inspection Prep
21 CFR 210/211 & ICH Q10

Altabrisa Group provides cell and gene therapy consulting for developers navigating the most complex manufacturing and regulatory environment in life sciences. Our consultants have direct, hands-on experience with ATMP quality systems, viral vector facilities, aseptic processing, and the FDA inspection expectations that apply to advanced therapy products — from early-phase clinical manufacturing through commercial licensure.

Platform Coverage

Cell & Gene Therapy Consulting Across All ATMP Platforms

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Autologous Therapy Developers

Chain-of-identity controls, patient-specific batch records, and GMP systems for personalized therapy manufacturing.

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Allogeneic Therapy Developers

Scale-up quality systems, donor material controls, and inspection-ready documentation for off-the-shelf platforms.

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Viral Vector Manufacturing

AAV, lentiviral, and adenoviral vector GMP — process controls, contamination strategy, and batch release systems.

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Plasmid & mRNA Manufacturing

GMP documentation, in-process controls, and quality oversight for plasmid DNA and mRNA starting material production.

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Aseptic Processing & Cleanrooms

EU Annex 1 alignment, environmental monitoring programs, and contamination control strategy for sterile CGT facilities.

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In-House & Outsourced Models

CDMO oversight, tech transfer compliance, and quality agreement support for companies using contract manufacturers.

What We Solve

Common CGT Compliance Gaps We Remediate

Batch variability and inconsistent investigations — root cause analysis frameworks built for complex, low-volume biologics manufacturing.
Chain-of-identity and chain-of-custody gaps — system design and SOP development to close traceability deficiencies before inspection.
Immature quality systems under regulatory pressure — rapid QMS buildout aligned to 21 CFR 210/211 and ICH Q10 for pre-BLA facilities.
FDA, EMA, and MHRA inspection preparation — mock audits, gap analysis, and real-time Person-in-Plant support during live inspections.
Deviation trending and CAPA effectiveness failures — backlog triage, recurrence prevention, and CAPA program redesign.
IND and BLA documentation gaps — quality section review, CMC support, and inspection readiness for pre-approval inspections.

Why Altabrisa

Why CGT Developers Choose Altabrisa Group

Deep CGT facility experience — consultants with hands-on background in viral vector, autologous, and allogeneic manufacturing environments.
Real-world GMP remediation — not theoretical gap lists. We implement, train, and close findings alongside your team.
Aligned to current regulatory expectations — 21 CFR 210/211, ICH Q7/Q9/Q10, FDA ATMP guidance, and EMA ATMP GMP requirements.
Remote and on-site support — embedded consultants or remote oversight depending on your stage and budget.
No junior consultants — every engagement is staffed with 20+ year senior specialists, not associates in training.
AdaptiStrat™ methodology — Assess, Remediate, Sustain. A structured framework that delivers compliance that holds.

Core Services

Our Cell & Gene Therapy GMP Consulting Services

QMS Design & Implementation

Build or remediate quality management systems from scratch for early-phase or commercial CGT facilities. SOPs, batch records, deviation management, and change control aligned to FDA and EMA expectations.

FDA Inspection Readiness

Mock inspections, pre-PAI gap analysis, and real-time Person-in-Plant support. We prepare your team for the questions FDA inspectors actually ask in CGT facilities.

Deviation & CAPA Management

Root cause analysis methodology, CAPA effectiveness evaluation, and deviation backlog triage for complex biologics manufacturing environments where standard pharma frameworks don’t always fit.

Data Integrity & 21 CFR Part 11

ALCOA+ frameworks, electronic records compliance, and audit trail review for CGT facilities operating with specialized manufacturing execution and LIMS systems.

Tech Transfer & CDMO Oversight

Quality agreements, tech transfer documentation, and CDMO audit support for CGT companies using contract manufacturers for viral vector or drug substance production.

IND / BLA Quality Support

CMC quality section review, IND amendment support, and BLA-readiness assessments to ensure your regulatory submissions reflect an inspection-ready quality system.

Regulatory Coverage

Regulatory Frameworks We Work Within

Our cell and gene therapy consulting is aligned to the full spectrum of applicable GMP regulations and guidance.

21 CFR Part 210 & 211

21 CFR Part 11 (Electronic Records)

ICH Q7 / Q9 / Q10

FDA ATMP Guidance Documents

EMA GMP for ATMPs

EU GMP Annex 1 (Sterile)

FDA Pre-Approval Inspection (PAI)

BLA / IND Documentation

MHRA GMP Requirements

WHO GMP Standards

USP <1116> Cleanroom Monitoring

ISO 14644 Cleanroom Standards

The Stakes

Why Cell & Gene Therapy Companies Can’t Wait on GMP

FDA inspections are earlier and more rigorous

Pre-approval inspections for CGT products now happen earlier in development. A weak QMS at BLA submission is a license delay, not just a finding.

Complex manufacturing leaves no margin for poor investigations

Low batch volumes, patient-specific products, and biological variability mean every deviation carries disproportionate risk. Root cause quality is non-negotiable.

Outsourced manufacturing adds oversight complexity

Most CGT companies use CDMOs for vector production or drug substance. Without rigorous oversight and quality agreements, your GMP exposure is your CDMO’s weakest system.

Immature QMS signals risk to regulators

FDA inspectors in CGT facilities specifically look for quality culture maturity. An underdeveloped QMS doesn’t just produce findings — it signals systemic risk across your entire program.