Analytical Development

Intertek's pharmaceutical contract laboratory services, regulatory assistance, and supply chain assurance deliver quality and safety to meet your unique pharma and biopharma outsourcing needs. We bring quality and safety to life!

With our pharmaceutical experts working with you at every stage of th...

Method Development and validation
Stability Studies
European testing & batch certification

Our analytical team provides a broad range of services including:

Drug Substance
...

TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract

Manufacturing ANALYTICAL DEVELOPMENT
• Monitoring of the first industrial manufacturing batches.
• Characterization of raw materials according to Pharmacopoeia.
...

As part of our turnkey custom development offer.

Determination of physical, chemical and technical properties of substances and chemical products

Solvias provides cGMP-compliant contract analytical services to help you ultimately provide safer products to consumers. We provide a comprehensive range of analytical services to the pharmaceutical, biotech, medical devices and cosmetics industry with similar regulatory requirements for raw materials,...

Take no risk with your analytics when developing new therapeutic monoclonal antibodies. Our analytical teams take advantage of their extensive experience in the analysis of mAbs. Throughout non-clinical and clinical development, our experts provide you with the customised solutions in terms of analytical pro...

The Confirmatory test consists in the assessment of which nitrosamines are present in the drug product below an acceptable limit, defined according to recommendations of EMA.

QPLab has in-house methods to determine nitrosamines based on the acceptable intake (AI)...

FORMULATION DEVELOPMENT 

NEW PRODUCTS DEVELOPMENT
SCALE UP STUDIES
QUALITY BY DESIGN PLANNING
MANUFACTURING TECHNOLOGY TRANSFER
EXECUTION OF SUBMISSION BATCHES
EXECUTION OF COMMERCIAL BATCHES
REGULATORY QUERIES RESPONSE & REMEDIATION


ANALYTICAL RESEARCH AND...

Patients are at the center of all our designs. We have been around for more than 60 years, and we know by experience that a "one size fits all" approach is the wrong approach when it comes to design. We need to understand your particular patient population, how these patients deal with their illness, and how ...

Our analytical experienced team support the pharmaceutical development during every phase of the development process. Analytical development transfer and validation, characterization capabilities, stability analysis, ICH Q3D (residuals solvent risk assesment), ICHQ3C (elemental impurities risk assesment) a...

In addition to client-funded research & analysis, OFI offers protein analysis under GMP with state-of-the-art methods and equipment: Our interdisciplinary experts accompany and evaluate your new developments with highly developed analytical methods, such as Protein identification, Protein quantificati...

Pharmaffiliates is providing all the Analytical Services (i.e. Method Development, Method Validation & Transfer, Stability Studies, Contract Analysis, etc)

Formulation development & clinical manufacturing of:   • Oral and topical applications  • Development of targeted release profiles for dosage forms  • BSL2 handling capabilities  • Aerobes, anaerobes and some spore formers  • Single strain and consortia products  • ...

Explicat Pharma GmbH also provides the know-how in developing food supplements. Contact us for more information.

Recipharm offer analytical support for drug discovery, pharmaceutical development and manufacturing through our global development facilities.

Samples, bulk products or drugs: Our experts analyze your product and evaluate whether it meets all individual and regulatory requirements. 

Among others our modern laboratory is equipped with:

• HPLC-systems • Dissolution testing • UV/Vis- and atomic absorption spectro...

TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract Manufacturing
We offer Stability Studies in short and long term,
according to ICH standards.

• Batchs of Registration.
• Industrial batches of finished pro...

With a full analytical package for Biologics, Quality Assistance provides scientific and technical support to biopharmaceutical companies developing Antibody-Drug Conjugates. Thanks to our combined experience with small molecule cytotoxics and monoclonal antibodies, we can provide full analyt...