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. 

 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.

GMP Bridge is 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.

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.

We work with both. Many of our clients are clinical-stage biotech companies transitioning from R&D to GMP. Others are established biopharma manufacturers or CDMOs. Our approach is always tailored to your company’s size, complexity, and needs. 

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 in regular contact with our network of independent senior consultants , so we always know who is available and suitable for each type of project.

Unlike recruiters or agencies, we do not send you a list of CVs to screen. Instead, we analyze your challenge and propose the specific consultant or team you need. Of course, you approve the final choice — but you will not waste time reviewing profiles or managing a recruitment process. Our focus is to solve your problem as efficiently as possible.

Yes. We regularly support investors, venture capital firms, 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 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.

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 much more than a document — it is a risk-based strategy that defines how your company prevents and controls contamination across your sterile manufacturing processes.

An effective CCS integrates facility design, equipment, material and personnel flows, aseptic practices, environmental monitoring, and cleaning — demonstrating to regulators that contamination risks are systematically identified, controlled, and documented.

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 that your strategy is grounded in real process understanding and focused where risks are highest.

Developing a robust, risk-based CCS is essential for Annex 1 compliance and 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.