GMP Solutions for Biotech & Cell and Gene Therapy
We provide Biotech GMP consulting and tailored solutions for cell and gene therapy companies navigating complex regulatory demands. Our senior consultants support you from clinical development to commercial manufacturing — ensuring compliance, accelerating product release, and building scalable Quality Systems for advanced therapies.
Discover how we support biotech innovators in achieving compliance, accelerating product release, and building robust quality systems for advanced therapies.
Our Core Services for Biotech and Advanced Therapies
Clinical-to-Commercial GMP Readiness
Transitioning from early clinical development to commercial manufacturing is one of the biggest challenges in biotech. Our biotech GMP services help you prepare for this shift by designing scalable Quality Systems, robust documentation practices, and risk-based oversight models. We ensure your clinical-to-commercial journey aligns with FDA, EMA, and Swissmedic expectations while maintaining efficiency and speed.
Regulatory & CMC Consulting (FDA & EMA)
Strong regulatory submissions require more than data — they require a clear CMC strategy. With our biotech regulatory and GMP consulting, we support IMPDs, INDs, BLAs, and MAAs by bridging science, manufacturing, and compliance. Our consultants ensure CMC dossier sections are inspection-ready and aligned with both U.S. and European health authority requirements, reducing regulatory risk and accelerating approvals.
QMS Design & Implementation for Clinical-stage Biotech
Many growing biotech companies inherit oversized or underdeveloped Quality Systems that don’t scale. We specialize in QMS design for biotech GMP compliance, creating fit-for-purpose frameworks that cover deviations, CAPAs, change control, and supplier qualification. Our focus is on lean systems that meet regulatory expectations without slowing your development timelines.
CDMO Evaluation, Qualification & Oversight
Relying on CDMOs is common in biotech — but oversight is often weak. We provide CDMO GMP oversight services that cover selection, qualification, and continuous supervision of your manufacturing partners. By establishing clear governance, risk-based monitoring, and structured escalation paths, we help ensure your CDMOs deliver GMP-compliant products while avoiding costly delays or compliance gaps.
Due Diligence Audits for Investors and Buyers
Biotech investors and buyers face high risks if GMP and operational gaps are missed. Our due diligence GMP audits identify compliance weaknesses, Quality risks, and remediation needs in acquisition targets. We provide clear, actionable reports that support valuation, negotiation, and post-deal integration — helping investors and strategic buyers make informed decisions with confidence.
Frequently Asked Questions
We are not focused on billable hours or theoretical frameworks. Every project is led by senior consultants with 20–30 years of hands-on experience in biopharma and advanced therapies manufacturing. We focus on solving critical GMP and Quality problems — quickly and pragmatically — where medicines are made.
We specialize in the life sciences sector, with a strong focus on:
– Biotechnology and Biopharmaceuticals: Supporting companies from clinical-stage biotech to commercial biopharma manufacturers.
– Cell and Gene Therapy (ATMP): Guiding advanced therapy developers and manufacturers through complex GMP and regulatory challenges.
– CDMOs and Contract Manufacturing: Helping contract development and manufacturing organizations (CDMOs) and their clients ensure quality, compliance, and operational excellence.
– Sterile Injectables and Parenteral Products: Enhancing sterility assurance, contamination control, and Annex 1 compliance in aseptic manufacturing environments.
Our team’s experience spans the full spectrum of GMP-regulated operations, from early-stage innovation to large-scale commercial supply. We work where medicines are actually made—and where quality and compliance are business-critical.
All our consultants are independent professionals or owners of their own consulting companies, not employees. We contract them through consulting service agreements between their companies and GMP Bridge. This guarantees full legal and tax compliance — without risks of “false self-employment” or similar issues in countries like Germany or Switzerland.
We guarantee a clear and compliant contractual setup, ensuring professional, transparent, and fully legal project delivery.
Both. We support clients at site level, corporate level, or both, depending on the project. Our clients range from global biopharma manufacturers with over 5,000 employees to small biotech startups with as few as 15 people. We adapt to your size, structure, and needs — whether supporting a single production facility or harmonizing processes across multiple international sites.
We mobilize quickly. If your situation is urgent, we recommend calling us directly — so we can understand your challenge and assemble the right team without delay.
Depending on your project scope and internal resources, we will decide together how to approach the work. In many cases, we can start within days or one week.
Our structure gives us immediate access to trusted senior consultants — without onboarding delays or lengthy selection processes. Our priority is to help you move forward as fast and effectively as possible.
We are based in Europe, with a strong presence in Germany, Switzerland, and Spain. However, we work globally. Our consultants support clients across North America, and we also manage projects involving suppliers and CDMOs in Asia and Latin America.
Our team includes consultants from multiple nationalities, and we work in languages such as German, Spanish, French, Italian, and Portuguese — ensuring smooth collaboration across regions.
You reach out:
Contact us via our website form, email (contact@gmpbridge.com), or by clicking “Schedule Your Call” to book a video meeting.
We listen:
Your first call or message is always with a senior consultant who speaks your technical language—not with a sales department (we don’t have one). We focus on your specific challenge, not on selling hours or generic solutions.
Expert match:
We connect you with a senior consultant or team who has solved similar problems before.
Solution & support:
We design and implement practical solutions, and remain available for follow-up to ensure lasting results.
No junior consultants, no unnecessary steps—just experienced professionals solving your most critical GMP challenges.
You have three easy options, depending on your situation:
Schedule a discovery call – Click on “Schedule Your Discovery Call” to book a video meeting with us in the coming days.
For urgent client enquiries – Call us anytime at (+49) 174 957 5861. This number is reserved for potential clients.
For all other enquiries – Please email us at contact@gmpbridge.com and we will respond from there.
We look forward to hearing from you.