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.
Yes. We regularly support investors, family offices and private equity companies involved in clinical-stage biotech, cell and gene therapies, and biopharma manufacturing.
We provide expert support during due diligence processes, helping identify GMP and Quality risks before acquisitions or investments. This includes assessing manufacturing readiness, Quality systems, regulatory compliance, CDMO dependencies, and operational bottlenecks.
If you are evaluating a biotech company, CDMO, or advanced therapy developer, we help you uncover risks that could impact product approval, supply chain, or future scalability — so you can make fully informed decisions before investing.
We specialize in solving critical GMP and Quality challenges for both clinical-stage biotech and established biopharma manufacturers. Our services are structured around two main areas:
For Biopharma Manufacturers:
Sterility Assurance & Annex 1 Compliance
CDMO Quality Oversight & Supplier Control
Inspection Readiness & Regulatory Remediation
Quality System Simplification & Harmonization
Aseptic Manufacturing Process Optimization
For Biotech & Cell and Gene Therapy Companies:
Clinical-to-Commercial GMP Readiness
QMS Design for Biotech Startups
CDMO Evaluation & Oversight
FDA Inspection Preparation (from a European perspective)
Due Diligence Audits for Investors and Buyers
You can explore all our services in detail on our Biopharma or Biotech & CGT Solutions page.
Yes. Many of our clients are European manufacturers preparing for FDA inspections — whether it is a Pre-Approval Inspection (PAI), a routine GMP inspection, or a for-cause visit.
We help companies prepare for FDA expectations from a European perspective, focusing on both technical readiness and cultural understanding of how FDA investigators approach audits. Our support includes:
– FDA inspection readiness assessments
– Mock FDA audits simulating actual inspection behavior
– Support with formal FDA meetings (Type C, pre-approval, post-warning letter)
– Preparation of inspection rooms and documentation flows
– Coaching of Quality and Operations teams for FDA interactions
– Remediation support after FDA 483s or warning letters
– Strategic advice for routine FDA oversight and compliance programs
We bring hands-on experience from past FDA inspections to help your team anticipate and respond effectively. Whether you are preparing for your first FDA inspection or managing remediation after findings, we support your site and leadership team every step of the way.
Why the name “GMP Bridge”?The name “GMP Bridge” embodies our mission to connect the critical elements that drive success in biopharma, biotech, clinical development, and cell & gene therapy (CGT).
In these highly regulated and rapidly evolving fields, we see ourselves as the bridge between:
– Quality and Key Departments: We connect Quality with Management, Production, Procurement, and R&D, ensuring that GMP principles are embedded across all functions—not just within the quality unit. This integrated approach is essential for the complex environments of clinical and advanced therapy manufacturing.
– Sponsors and CDMOs: We facilitate clear communication and alignment between sponsors and their CDMOs, especially in clinical and CGT projects where expectations, timelines, and compliance requirements are particularly demanding. Our role is to ensure that both sides work together seamlessly to achieve project goals and regulatory success.
– Compliance and Excellence: We help organizations move beyond basic compliance to achieve true quality excellence. In biopharma, biotech, and CGT, this means not only meeting regulatory requirements but also building robust, future-ready systems that support innovation and patient safety.
Our name reflects our commitment to being the connector—helping our clients navigate complexity, foster collaboration, and achieve both compliance and operational excellence in the most advanced areas of life sciences.
Good Manufacturing Practice (GMP) is the system of regulations that ensures medicines and therapies are consistently manufactured and controlled according to quality standards. GMP covers the entire production process — from raw material handling to final product release — and applies to all types of pharmaceuticals, including biologics and advanced therapies.
In practice, GMP is about controlling risks to ensure patient safety and product quality.
Annex 1 is the section of the EU GMP Guidelines focused on the manufacture of sterile medicinal products. It sets specific requirements for contamination control, aseptic manufacturing, and cleanroom operations.
Compliance with Annex 1 is mandatory for companies producing sterile biologics, vaccines, and advanced therapy products within the EU or supplying the European market.
Annex 1 now requires companies to establish a formal Contamination Control Strategy (CCS) as a key regulatory expectation.
A Contamination Control Strategy (CCS) is far more than just a document—it is a comprehensive, risk-based approach that defines how your company prevents and controls contamination throughout all sterile manufacturing processes.
An effective CCS integrates facility design, equipment, material and personnel flows, aseptic practices, environmental monitoring, and cleaning. Its purpose is to demonstrate to regulators that contamination risks are systematically identified, controlled, and documented.
Importantly, developing and maintaining a robust CCS is a new and explicit requirement of the EU GMP Annex 1 (2023 revision). It is also a clear expectation of other leading health authorities, such as the FDA, who are increasingly focused on holistic contamination control and sterility assurance.
At GMP Bridge, we approach CCS development as a strategic process—not a checklist. We typically combine the CCS with a detailed, risk-based Contamination Control Risk Assessment (CCRA), ensuring your strategy is grounded in real process understanding and focused where risks are highest.
Building a strong, risk-based CCS is essential not only for Annex 1 compliance and meeting global regulatory expectations, but also for achieving true sterility assurance—not just on paper, but in daily operations.
CDMO oversight refers to the management and control of your outsourced manufacturing partners (Contract Development and Manufacturing Organizations). This includes evaluating potential CDMOs, qualifying them, and maintaining ongoing oversight to ensure they meet regulatory standards, protect your product quality, and do not introduce supply chain risks.
Effective CDMO oversight is not just about audits — it involves quality agreements, performance monitoring, deviation handling, and clear escalation processes.
Clinical GMP applies to investigational medicinal products (IMPs) used in clinical trials. It typically involves smaller batch sizes, flexible processes, and a leaner Quality Management System (QMS) adapted to development-stage needs.
Commercial GMP applies to products intended for sale, requiring validated processes, stricter change control, and a more robust, scalable QMS. Moving from clinical GMP to commercial GMP is a critical transition — often underestimated — that impacts compliance, supply chain readiness, and even investor confidence.
A Pre-Approval Inspection (PAI) is an FDA inspection conducted before a new product is approved for the US market. Its goal is to verify that your facility, processes, and Quality systems are ready for commercial supply. Failing a PAI can delay product launch significantly.
PAI readiness is not just about documentation — it requires ensuring your entire site, leadership team, and operators are inspection-ready.
A Qualified Person (QP) is a regulatory requirement in the EU for the release of medicinal products. The QP is responsible for ensuring that each batch of drug product is manufactured and tested in compliance with GMP, the marketing authorization, and all relevant regulations. The QP plays a critical role in batch certification, oversight of manufacturing and testing activities, and ensuring product quality and patient safety.
A Quality Management System (QMS) is the foundation of GMP compliance. It encompasses all policies, procedures, processes, and resources needed to ensure that products are consistently manufactured to the required quality standards. A robust QMS covers document control, training, deviation management, CAPA, change control, and continuous improvement, supporting both regulatory compliance and operational excellence.
Data integrity refers to the completeness, consistency, and accuracy of data throughout its lifecycle. In GMP environments, data integrity is essential for ensuring that manufacturing and quality decisions are based on reliable information. Regulatory agencies like the FDA and EMA expect companies to implement controls that prevent data manipulation, loss, or unauthorized access, as data integrity failures can compromise product quality and patient safety.
GMP-compliant cleanroom design is essential for sterile manufacturing. Key requirements include appropriate air filtration (HEPA), controlled airflows, pressure differentials, temperature and humidity control, and materials and finishes that are easy to clean and resistant to contamination. Cleanroom classification (e.g., ISO 5, ISO 7) and environmental monitoring are also critical to maintaining compliance and product sterility.
GMP requirements for biologics are generally more complex than for small molecules due to the nature of biological products. Biologics manufacturing involves living cells, which introduces additional risks for contamination, variability, and process control. As a result, GMP for biologics emphasizes aseptic processing, environmental monitoring, and robust control strategies, while small molecule GMP focuses more on chemical synthesis and analytical testing.
Batch release is the formal process by which a batch of product is reviewed and certified as meeting all quality and regulatory requirements before it can be distributed. This process involves a comprehensive review of manufacturing and testing records, deviation and change control documentation, and final approval by the Qualified Person (QP) or responsible authority. Batch release is a critical control point for ensuring product quality and patient safety.
A deviation is any departure from approved procedures, specifications, or expected results in a GMP environment. All deviations must be documented, investigated, and assessed for impact on product quality and patient safety. Effective deviation management includes root cause analysis, implementation of corrective and preventive actions (CAPA), and timely closure to prevent recurrence and maintain compliance.
Cell and gene therapy (CGT) manufacturing presents unique GMP challenges, including complex supply chains, short product shelf lives, and high variability in starting materials. Ensuring aseptic processing, robust chain of identity and custody, and rapid release testing are critical. Regulatory expectations for CGT are evolving, making it essential to implement flexible, risk-based quality systems that can adapt to new guidance and technologies.