SPECIALIZING IN SOLID-STATE CHARACTERIZATION
GMP certified contract laboratory – Experts in Size and Crystals
Your solid-state characterization specialist
As GMP certified contract laboratory, Particle Analytical provides end-to-end support across the pharmaceutical value chain, from early discovery through full-scale commercialization.
Solid-state characterization services streamline development, ensure compliance, and optimize product performance of pharmaceuticals at each stage. Focused on solid-state analysis, our GMP certified laboratory brings expertise to every project, supporting data-driven decisions that reduce risk and accelerate timelines.
Whether advancing new candidates or upholding quality in production – Particle Analytical delivers results as reliable partner for the pharmaceutical industry.
Specialized support at every stage of pharma development
Discovery & Preclinical Development
Clinical Development
Regulatory Review & Approval
Manufacturing & Commercialization
Get a comprehensive analysis of your product
When you outsource a specific analysis to us, we will do our best to guide you in the selection of the analysis and parameters.
We can support your in-house capabilities, or we can complement them.
GMP analytical and testing laboratory services at Particle Analytical
As a GMP certified laboratory, Particle Analytical provides GMP analytical and testing laboratory services across the pharmaceutical value chain. Our expertise supports early development, clinical programs, regulatory submissions, and commercial manufacturing.
Our GMP testing laboratory services include solid-state characterization, method development and validation, bioequivalence studies, troubleshooting investigations, and quality control measurements of critical quality attributes. All services are delivered under GMP conditions, ensuring that analytical data is suitable for regulatory decision-making and compliance requirements.
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Knowledge Hub
Explore our Knowledge Hub for regulatory guidelines, publications and events. Find also answers on frequently asked questions.
How we can help
We can find the root cause for problems in development or manufacturing processes. Our experts will listen to your need and offer tailored solutions.
Why choose us
By choosing Particle Analytical, you chose highest quality standard. We are a GMP certified contract laboratory, specialised in pharmaceutical drug development and manufacturing testing.
How GMP certification supports regulatory submissions
GMP certification ensures that analytical data is generated under controlled and documented conditions that meet regulatory expectations. Data produced in a GMP certified laboratory can be used directly to support regulatory submissions, batch release decisions, and responses to authority questions.
By working under GMP conditions, Particle Analytical provides analytical results that are traceable, reproducible, and suitable for review by regulatory authorities such as the FDA and EMA.
GMP certification across the pharmaceutical lifecycle
GMP certification plays a role throughout the pharmaceutical lifecycle. During clinical development, GMP-compliant analysis supports the generation of reliable data for regulatory submissions. In manufacturing and commercialization, GMP ensures consistent quality control and audit readiness.
As a GMP certified laboratory, Particle Analytical supports pharmaceutical companies from early development through full-scale manufacturing with analytical data aligned to regulatory requirements.
Enjoy the simplicity of outsourcing
Ship your samples.
We analyse them and send you a comprehensive report.
It is that simple!
Recent news
Importance of X-ray Powder Diffraction (XRPD) in Identifying Polymorphic Forms
In pharmaceutical development, it is not enough to know what your compound is – you must also know which form it is in. Many active pharmaceutical ingredients (APIs) exist in multiple solid-state forms : polymorphs, hydrates and salts. These forms can differ significantly in properties such as solubility, bioavailability, stability...
Open House: 28 th march 2025
Join Particle Analytical’s 25th Anniversary We invite you to Particle Analytical’s Open House as we celebrate 25 years of expertise in solid-state characterization. This in-person event is a great opportunity to connect, learn, and experience our laboratory capabilities firsthand. Visit the Particle Analytical Laboratory on March 28, 2025, from 1:00...
Benefits of Laser Diffraction Analysis
Laser Diffraction is the most widely used technique for measuring particle size distribution (PSD) in pharmaceutical materials due to several key advantages: 1. Wide Measurement Range 2. Rapid and High-Throughput Analysis 3. Non-Destructive and Minimal Sample Preparation 4. High Reproducibility and Accuracy 5. Suitable for Dry and Wet Dispersions 6....
25 years of diversity – Particle Analytical laboratory
What makes Particle Analytical truly special? Is it our laboratory GMP certification? Our deep expertise in Solid-State Characterization? Or perhaps Søren Kristensen as enthusiastic CEO with a strong vision and an unwavering belief in making a difference? Maybe. Maybe not. What truly sets us apart is our people – the...
25 Years of innovative Solid-State Characterization
As Particle Analytical celebrates its 25th anniversary, we sat down with founder and CEO, Søren Kristensen, to reflect on the journey, achievements, and the future of solid-state characterization. A vision born from curiosity “25 years ago, the industry relied heavily on microscopy, believing we had full control. But when we...
Analytical Method Validation: A Crucial Pillar in Pharmaceutical Quality Assurance
In the pharmaceutical industry, ensuring the consistent production of high-quality, reliable, and cost-effective products is paramount. Analytical chemistry, a key discipline in this process, focuses on identifying (qualitative) and quantifying (quantitative) components in substances or mixtures. Analytical method validation is essential for fully GMP testing before release. It guarantees reliable,...
Frequently asked questions
What is a GMP certified laboratory?
A GMP certified laboratory operates under Good Manufacturing Practice requirements, ensuring that analytical work is performed in a controlled and documented environment. GMP certification confirms that laboratory processes, data handling, and quality systems meet regulatory expectations for pharmaceutical development and manufacturing.
Analytical results generated in a GMP certified laboratory are fully traceable and suitable for regulatory use, including development support, batch release, and submissions. Particle Analytical is a GMP certified contract laboratory delivering analytical services aligned with international pharmaceutical standards.
What is the difference between a GMP and non-GMP laboratory
The primary difference between a GMP and a non-GMP laboratory lies in regulatory control, documentation, and data integrity. In a GMP certified laboratory, analytical work is performed under validated procedures with full traceability and quality oversight.
Non-GMP laboratories may generate sound scientific data, but results are often not acceptable for regulatory submissions or batch release without additional justification. GMP laboratories provide audit-ready data aligned with regulatory expectations, making them essential partners in pharmaceutical development and manufacturing.
Why is GMP certification important?
GMP certification ensures data integrity, traceability, and regulatory acceptance. It reduces risk during inspections, batch release, and regulatory submissions.
What types of companies require GMP laboratory data?
Pharmaceutical companies developing, manufacturing, or commercializing drug products require GMP laboratory data to meet regulatory expectations.
How is GMP compliance maintained in a laboratory?
Through validated methods, controlled documentation, trained personnel, regular audits, and readiness for regulatory inspections.
What does GMP certification mean in pharmaceutical analysis?
In pharmaceutical analysis, GMP certification means that analytical activities are performed under defined quality systems that ensure consistent, accurate, and reproducible results. GMP governs how samples are handled, how methods are applied, how data is documented, and how deviations are investigated.
GMP certification is an ongoing commitment that requires maintained procedures, validated methods, and readiness for regulatory inspection. By operating as a GMP analytical laboratory, Particle Analytical ensures that analytical data is reliable and suitable for regulatory review throughout the pharmaceutical lifecycle.
Is GMP certified the same as FDA certified?
GMP certification and FDA certification are closely related but not the same. GMP refers to a quality system that governs how pharmaceutical products and analytical data are generated. The FDA is a regulatory authority that inspects and enforces compliance with GMP requirements.
A GMP certified laboratory operates in accordance with GMP guidelines and is prepared for inspection by regulatory authorities such as the FDA or EMA. FDA inspections assess whether a laboratory’s GMP systems are implemented and maintained correctly, but the FDA does not “certify” laboratories in the same way as a formal accreditation.
Particle Analytical operates under GMP conditions and aligns its analytical practices with FDA and EMA expectations, ensuring regulatory acceptance of generated data.
