Analytical method development and validation

Analytical methods developed, validated to ICH Q2 and transferred to other laboratories.

23 providers with evidence Sourced from law and guidelines · as of 10.11.2026 View providers

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In brief

Every test of a medicinal product is only as good as the method used to perform it. In method development, an analytical procedure is designed so that it reliably measures the desired attribute of an active substance or medicinal product, such as assay, impurities or identity. Validation then demonstrates with documented experiments that the method is fit for this purpose. In method transfer, a validated method is moved to another laboratory, where it is demonstrated that the method delivers equivalent results.

Since 2024, two aligned ICH guidelines have been available for this in the EU: ICH Q14 for the development and lifecycle of a method, and the revised ICH Q2(R2) for validation. Anyone who has a method developed or validated today should follow both.

Who needs it

Applicants before marketing authorisation, manufacturers when changing methods, and anyone moving testing to another laboratory.

Legal basis

ICH Q2(R2) and ICH Q14, applicable in the EU since 14 June 2024, as well as Chapter 6 of the EU GMP Guide.

Typical scope

Development, validation protocol, validation experiments, report and, where applicable, transfer to the routine laboratory.

What matters

A clearly described purpose of the method, robustness data from development and a clean transfer.

When you need it

The greatest need arises before the marketing authorisation. Validated methods must be in place for release and stability testing of the active substance and the finished product, and their validation data belong in the marketing authorisation dossier. In clinical development, the principles of Q2(R2) and Q14 can be applied in a phase-appropriate way, meaning with a scope that matches the stage of development.

After authorisation, new needs arise when a method is changed, replaced by a new technique or moved to another laboratory. This may be a change of contract laboratory, the relocation of release testing to another site or the takeover of a product from another manufacturer. Stability studies also need methods that reliably detect degradation of the active substance.

Legal basis and rules

ICH Q2(R2)

Validation of analytical procedures: which performance characteristics must be demonstrated for which type of method and which data belong in the submission.

ICH Q14

Development of analytical procedures with a minimal or enhanced approach, analytical target profile and lifecycle management.

EU GMP Guide, Chapter 6

Methods must be validated. A laboratory that did not validate a method itself verifies its suitability. A protocol and a report are required for transfer.

ICH Q12

Tools for post-approval changes, to which Q14 refers for analytical procedures.

Validation under ICH Q2(R2)

Q2(R2) applies to methods for release and stability testing of active substances and medicinal products and can be applied on a risk basis to other methods in the control strategy. Which characteristics must be demonstrated depends on the purpose. For assays and quantitative impurity tests, these usually include specificity, range with calibration model, accuracy and precision, and for impurities also the quantitation limit. For identity tests, demonstrating specificity is usually sufficient. Before validation, a protocol with purpose, characteristics and acceptance criteria is prepared, and afterwards a report. Under Q2(R2), robustness is typically investigated during development, and suitable development data may be used as part of the validation data.

Development under ICH Q14

Q14 distinguishes a minimal, traditional approach from an enhanced approach. Both are acceptable. In the enhanced approach, the intended performance characteristics are recorded in an analytical target profile, influencing factors are identified through a risk assessment and their interaction is studied in series of experiments. This can result in established operating ranges that make later changes easier. Under Q14, formally submitting an analytical target profile is voluntary.

Method transfer

Under Chapter 6 of the EU GMP Guide, the transferring laboratory checks before the transfer whether the method complies with the marketing authorisation and compares the original validation with current ICH requirements. Gaps are recorded in a documented analysis. The transfer itself follows a protocol covering the tests to be transferred, training needs, samples and standards, transport conditions and acceptance criteria based on the current validation. Q2(R2) lists partial or full revalidation, comparison of representative samples or co-validation at several sites as possible approaches.

How the collaboration works

Purpose and requirements

You describe what the method is to measure and which specification limits apply. In the enhanced approach, this becomes an analytical target profile.

Development

The laboratory selects the technique, optimises the conditions, investigates robustness and defines a system suitability test. For stability methods, this includes stress studies.

Validation protocol

The protocol defines performance characteristics, experimental design and acceptance criteria and is approved before work starts.

Validation and report

The experiments are performed and summarised in a report that can be used for the dossier.

Transfer to routine use

If routine testing takes place in another laboratory, the method is transferred according to a protocol and the transfer is closed with a report.

What to look for when choosing a laboratory

Questions to ask the provider

Does the laboratory perform validations under GMP, and can this be demonstrated?

Is it familiar with the enhanced approach under ICH Q14, and does it use statistical design of experiments?

Does it have experience with your technique and product class, such as chromatography, spectroscopy or biological potency assays?

What do the protocol and report look like, and can they be taken over into the dossier without rework?

Who approves protocols, and how are deviations during validation handled?

Can the laboratory later also run the method in routine testing, or is a transfer planned?

How are raw data, the audit trail and evaluation software protected against alteration?

Frequently asked questions

Do existing methods have to be revalidated under Q2(R2)? +

Usually not. The ICH training materials from 2025 make clear that Q2(R2) generally does not apply retrospectively to methods validated before the guideline was adopted. This changes as soon as an existing method is changed in a way that requires revalidation and notification to the authority. The EMA also describes the scope as new or changed methods. The extent of a revalidation depends on the characteristics affected by the change. Chapter 6 of the EU GMP Guide also requires that, before a method transfer, the original validation is compared with current ICH requirements and gaps are closed. At that point at the latest, the question becomes practical.

Do pharmacopoeial methods need validation? +

Under Chapter 6, a laboratory that did not validate a method itself must verify its suitability. For pharmacopoeial methods, this usually means demonstrating that they work with your product.

Is the enhanced approach under Q14 mandatory? +

No. The minimal approach remains expressly acceptable. The enhanced approach requires more effort at the start, but can make later changes easier because the influencing factors and their limits are already documented.

How much validation does a method need in Phase 1? +

Q2(R2) and Q14 provide for their principles to be applied in a phase-appropriate way during clinical development. You should define the specific scope with regard to the requirements for the investigational medicinal product and together with your regulatory affairs department.

Sources

Every statement in this text was checked against these primary sources (as of 10.11.2026). Laws, guidelines and authority websites, no advertising.

Providers

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Company	Location	EvidenceQuote from the company’s website (German)	Credentials
A&O Pharma GmbH A&O Pharma GmbH, based in Efringen-Kirchen with sites in Itzehoe and Lörrach, provides service support to pharmaceutical companies, including batch certification by Qualified Persons, regulatory affairs, GMP consulting and GMP-certified analytics.	Efringen-Kirchen	Evidenced „Wir entwickeln und validieren Ihre Analysenmethoden und führen spezielle Prüfungen wie Spurenanalytik (z. B. Nitrosamine) durch.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
AGON Pharma GmbH AGON Pharma GmbH, based in Wendlingen, provides contract analytical services for batch release testing, stability studies in climatic chambers, and method validation and marketing authorisation support for medicinal products of other companies.	Wendlingen Am Neckar Baden-Württemberg	Evidenced „we are able to perform validation activities based on your specifications and in compliance with the ICH Guideline Validation of Analytical Procedures Q2 (R1)“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Abx Advanced Biochemical Compounds - Biomedizinische Forschungsreagenzien GmbH ABX Advanced Biochemical Compounds GmbH, based in Radeberg, develops, synthesises and manufactures radiopharmaceuticals as well as precursors, active pharmaceutical ingredients and reference standards, including under contract manufacturing arrangements (CDMO/CMO), and supplies them worldwide.	Radeberg Sachsen	Evidenced „Development of analytical methods based on CQA including a dedicated HPLC method being able to separate all radiochemical impurities“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Aescuven Pharma Deutschland GmbH & Co. KG Aescuven Pharma Deutschland in Baden-Baden manufactures herbal medicinal products on a contract manufacturing basis and offers contract analytical testing according to the European Pharmacopoeia. The site is part of the Shenzhen Xingyin Group.	Baden-Baden Baden-Württemberg	Evidenced „Wir führen die Validierung analytischer Verfahren gemäß den geltenden ICH-Guidelines durch.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Amcapharm Pharmaceutical GmbH AMCAPHARM Pharmaceutical GmbH, based in Rosbach, manufactures suppositories and liquids on a contract basis, packages and labels them, and provides analytical testing, stability studies and method validation for its clients.	Rosbach Hessen	Evidenced „Entwicklung analytischer Methoden Validierungen analytischer Verfahren nach ICH Q2“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Biochem Labor Für Biologische Und Chemische Analytik GmbH	Karlsruhe Baden-Württemberg	Evidenced „Validierung/Verifizierung von Verfahren/produktspezifische Validierung gemäß ICH-Guidelines inklusive Prüfplan und Berichterstellung in Absprache mit dem Kunden“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Chromicent GmbH Chromicent GmbH, based in Berlin-Adlershof, develops and validates chromatographic analytical methods under Quality by Design (QbD) principles and analyses impurities for clients. The company also carries out GMP audits at contract laboratories.	Adlershof Berlin	Evidenced „Analytische Methodenvalidierung in compliance mit regulatorischen Vorgaben (ICH Q2)“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Ever Pharma Jena GmbH EVER Pharma Jena GmbH in Jena is a production site of the EVER Group for sterile injectable solutions. It carries out contract manufacturing and packaging of medicinal products, and offers analytical testing and stability studies.	Jena Thüringen	Evidenced „We can develop new methods in-house or transfer existing validated methods to meet your product specifications.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Excella GmbH & Co. KG Excella GmbH & Co. KG in Feucht bei Nürnberg manufactures active pharmaceutical ingredients, tablets and capsules on a contract basis, in some cases up to and including packaging. The company also provides method transfer and validation services for its clients.	Feucht Bayern	Evidenced „Wir transferieren die Methoden unserer Kunden in unsere Labors und validieren diese auch.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Flavine Europe GmbH Flavine Europe GmbH, based in München, brokers active pharmaceutical ingredients and finished medicinal products and offers laboratory testing in Marseille, regulatory support for manufacturers' dossiers, and logistics with cGMP-compliant warehousing.	München Bayern	Evidenced „Analytical method development, validation and transfer“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
MLM Medical Labs GmbH MLM Medical Labs GmbH, based in Mönchengladbach, operates a central laboratory for clinical trials, providing sample analysis, biomarker assays and sample storage for pharmaceutical and biotech clients.	Mönchengladbach	Evidenced „We perform validation with a fit-for-purpose approach, which may include adherence to EMA and FDA guidelines for bioanalytical method validation.“ Source · 10 Nov 2026 ↗
MyBiotech GmbH MyBiotech GmbH in Ueberherrn is a nanomedicine CDMO that develops nanoparticle formulations, manufactures them under sterile conditions, and provides quality testing and stability studies for its clients.	Ueberherrn Saarland	Evidenced „Our scientists develop and validate analytical methods specifically for nanomedicine and nanoparticle-based drug products.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
NMI Technologietransfer GmbH NMI Technologie Transfer GmbH in Reutlingen develops and operates contract research services for pharmaceutical and biotech companies, covering protein profiling, cell assays and electrophysiology, as well as microdevices.	Reutlingen Baden-Württemberg	Evidenced „With many years in setting up custom immunoassays, we develop and validate assays on demand.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Nuvisan GmbH Nuvisan GmbH, based in Neu-Ulm, is a contract research organisation (CRO) with laboratories in Germany and France. It conducts clinical trials and recruits trial participants at its own clinical research sites.	Neu-Ulm Bayern	Evidenced „Building on a long-standing history of expertise in the development and validation of analytical methods, we have the internal capabilities to conduct method development“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Pensatech Pharma GmbH Pensatech Pharma in Berlin is a contract research partner for dosage forms. The company offers formulation development, analytical services, GMP quality control and stability studies to other pharmaceutical companies.	Adlershof Berlin	Evidenced „Development, optimization and validation of physicochemical and pharmaceutical analytical methods: Compendial methods Non-compendial methods In-house developed methods“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Phytolab GmbH & Co. KG PhytoLab GmbH & Co. KG in Vestenbergsgreuth is an accredited testing laboratory for herbal medicinal products, foodstuffs and animal feed, with a focus on quality control, trace analysis and reference substances.	Vestenbergsgreuth Bayern	Evidenced „Die Methodenvalidierung erfolgt nach den ICH-Richtlinien CPMP/ICH/281/95 und 381/95.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
QMEDIS Analytics GmbH QMEDIS Analytics GmbH, based in Potsdam, is a GMP-certified contract laboratory for analytical testing, stability studies and pharmaceutical formulation development, with a focus on cannabis and narcotic substance testing.	Potsdam Brandenburg	Evidenced „Methodenentwicklung, -validierung und -transfer: Entwicklung individueller, normgerechter Analysenmethoden sowie deren Validierung und reibungsloser Transfer“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Rentschler Biopharma SE Rentschler Biopharma SE in Laupheim is a CDMO for biopharmaceuticals, with a focus on process development, cGMP manufacture of recombinant proteins and analytical development for customers worldwide.	Laupheim Baden-Württemberg	Evidenced „Unsere Services reichen von der Entwicklung, Etablierung, Qualifizierung und Validierung von Methoden bis hin zu Transfers von analytischen Methoden.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Rottendorf Pharma GmbH Rottendorf Pharma GmbH, based in Ennigerloh, is a contract manufacturer of solid oral dosage forms. It produces batches of 2 to 750 kg, packages them, and provides stability and analytical services to its customers.	Ennigerloh Nordrhein-Westfalen	Evidenced „We have many years of experience in method development and validation as well as in raw material and finished product analysis of commercial products.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
RubiePharm Arzneimittel GmbH RubiePharm Arzneimittel GmbH, based in Steinau an der Straße, carries out contract manufacturing of suppositories, ovules, ointments, creams and gels, as well as food supplements. Its services include packaging, material sourcing and stability programmes.	Steinau Hessen	Evidenced „Validierung oder Transfer analytischer Methoden“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Tentamus Pharma & Med Deutschland GmbH	Oldenburg Niedersachsen	Evidenced „entwickeln und validieren wir auch individuelle Prüfmethoden für Produkte, die nicht (nur) entlang definierter Standards geprüft werden.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Wiewelhove GmbH Wiewelhove GmbH in Ibbenbüren is a contract manufacturer of solid dosage forms such as tablets, capsules and coated tablets. Its services include packaging, in-house analytical testing, and validation and project management.	Ibbenbueren Nordrhein-Westfalen	Evidenced „Sowohl der gesamte Herstellungsprozess als auch die Analysenmethoden werden nach zuvor mit dem Kunden abgestimmten Plänen validiert.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
nuvalore GmbH nuvalore GmbH, based in Leimen, provides analytical services for the pharmaceutical industry, including method development and validation, stability and release testing, and consultancy on Quality by Design.	Leimen Baden-Württemberg	Evidenced „Bei nuvalore bieten wir GMP-konforme End-to-End-Dienstleistungen zur Entwicklung, Validierung und zum Transfer analytischer Methoden“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate

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