PPD Laboratory Services, GMP Lab
GMP pharmaceutical testing solutions and services
Our GMP lab provides comprehensive drug substance / drug product (DS/DP) analytical testing with first-time accuracy.
As a leading provider of chemistry, manufacturing and controls (CMC) lab services, we focus on addressing needs with the latest technology, quality service and a high degree of flexibility. Our services meet the requirements of regulatory authorities worldwide, providing analytical services for small molecules and biologics for all phases of drug development. This includes active pharmaceutical ingredients (APIs), drug products, inhaled products, cell and gene therapies and drug-device combination products.
State of the art lab facilities and extensive experience
Variability in GMP lab performance often leads to delay, regulatory risk, and cost creep—especially with more complex molecules and compressed timelines. When labs operate reactively or lack integration between development and GMP testing, data inconsistencies, late-stage deviations, and delays can occur, impacting timelines and regulatory outcomes.
In addition to providing testing, our GMP lab is structured to reduce downstream risk and accelerate decision-making. Our harmonized quality management system (QMS) within the lab network also drives consistency in data and processes, which is critical for smoother regulatory submissions. The result: fewer delays, stronger data integrity, and more confidence in your path to approval—in addition to completed testing.
Shorten your development timelines with our GMP lab
We focus on eliminating bottlenecks so customers can shorten the time from sample arrival to report—helping customers protect clinical and release timelines. Using a speed of delivery mindset, we have industry-leading cycle times of up to 40% reduction.
Accelerate the journey to reach your end goals with speed and confidence
State-of-the-art facilities and experienced personnel ensuring agility and speed
- Analytical development and validation for drug products and devices, starting materials, APIs, and more
- Stability testing and storage
- Release and quality control testing
- Inhaled pharmaceutical and biologics testing
- Physiochemical characterization
- Specialized expertise in mass spectroscopy
- Potency bioassay and molecular biology applications
- Microbiology
- CMC advisory services
- Impurity identification and characterization
- Qualified person (QP) release services
- Infectivity
Our GMP lab met or exceeded expectations for quality of analytical testing for 98% of our customers
We are ready to partner with you
Our GMP lab, by the numbers
Founded three decades ago, our GMP lab, with locations in the U.S. (Wisconsin) and Europe (Ireland), has a deep-rooted industry commitment and strong global presence to keep pace with growing and changing industry needs.
square feet of lab space in the U.S and Europe
scientists and staff across the globe
years of meeting customers’ CMC testing needs
The industry standard of GMP labs
Through industry-leading cycle times, flexible engagement models, and a globally aligned solution under one QMS with strong regulatory history, we enable customers to move fast with confidence.
- Scientific and regulatory expertise to inform data-driven decisions
- Customized testing services offered to accelerate and enhance the drug development journey.
- Efficiency and flexibility to ensure critical timelines are met without compromising quality.
- Fit for purpose, phase-appropriate service offerings, with options for scalability
The GMP Analytical difference
Scientific Resourcing
Onsite industry-leading laboratory operations expertise
We offer highly customized testing programs designed specifically to for your organization and its unique requirements. Our integrated workforce solutions feature scientific expertise with strong operational acumen, and we embed teams directly into our lab for improved performance.
Related resources
Learn more about how we can help with your needs.
FAQs
We provide comprehensive GMP analytical testing services for drug substances and drug products, including small molecules, biologics, APIs, inhaled products, cell and gene therapies, and combination products across all phases of drug development.
Some factors to consider when choosing a GMP/CMC contract lab include:
- scientific expertise
- regulatory track record
- analytical capabilities
- quality systems
- capacity
- turnaround times
- program support across development stages.
The PPD Laboratory services GMP lab, a leading provider of CMC lab services, offers customers the latest technology, quality service and a high degree of flexibility. Our analytical services meet the requirements of regulatory authorities worldwide, for small molecules and biologics across all phases of drug development.
The GMP lab supports active pharmaceutical ingredients (APIs), finished drug products, inhaled pharmaceuticals, biologics, cell and gene therapies, and drug-device combination products.
GMP labs offer many services. The PPD Laboratory services GMP lab provides:
- Analytical development and validation
- Stability testing and storage
- Release and quality control testing
- Microbiology
- Potency bioassays
- Mass spectrometry
- Physicochemical characterization
- Impurity identification and characterization
- Qualified Person (QP) release services
- CMC advisory services
GMP pharmaceutical testing can help speed up the drug development journey by reducing downstream risk and accelerating decision-making. Our GMP lab delivers industry-leading report cycle times up to 40% faster than traditional approaches by focusing on reducing bottlenecks and shortening sample-to-report timelines.
Yes, our GMP lab customizes solutions to meet distinct customer needs. This includes flexible engagement models, customizable testing solutions, scientific and regulatory expertise, scalable services, and a globally aligned quality management system (QMS).
We offer Scientific Resourcing solutions to address lab staffing, capacity and operational needs. Through customized Scientific Resourcing, we embed experienced laboratory personnel at customer sites, providing flexible workforce solutions and operational expertise tailored to project needs.
Learn more about PPD Laboratory services GMP lab
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