Development & Validation of Analytical Methods

Sarjen Systems’ QEdge is an enterprise-wide Quality Management System (QMS) specifically designed for pharmaceutical manufacturing. This risk-based QMS offers a comprehensive suite of solutions, including:
• Process Control • Document Control & Issuance • Training Management System • Ve...

Clearsynth provides a wide range of high-purity NMR solvents designed to ensure optimal resolution and reliable analysis, supporting both research and quality control applications 

Benzene D6 , Chloroform-D , Dimethyl Sulphoxide D6 (DMSO D6) , Methanol D4 , Deuterium Oxide , Tetrahydrofuran...

Characterisation of bispecific antibodies supporting regulatory considerations for therapeutic development. Our scientists offer BsAb characterisation, with a focus on monitoring relevant CQAs. We can help you to demonstrate consistency or comparability of manufactured batches or as release tests for clin...

ROA spectrometer for measurement of absolute configuration of small molecules and structural motifs of biologics. 

With a team of experienced scientists and a robust toolbox of analytical techniques and equipment, Experic can support the life cycle of your oral solid dose and/or inhalation pharmaceutical products. Our laboratory staff provides comprehensive analytical solutions to support the formulation, development, ...

Comprehensive analysis during formulation development and GMP manufacture is vital to ensure that your drug has optimal delivery properties and stability profile as well as supporting your regulatory submissions.

Method Development and validation
Stability Studies
European testing & batch certification

Analytical Services: QC Chem/Microbio, stability, etc.

We have the experience, expertise, and facilities at Sever Pharma Solutions to safely work with your high-potent substances. This includes manufacturing products containing APIs that are ranked in the highest occupational exposure bands (OEB) up to and including OEB6.

Our focus on safety starts ...

When you work with Celanese you have access to the right mix of services, support, and proven materials to accelerate your drug delivery program through technical feasibility. The Celanese Development & Feasibility Lab offers formulation development, drug release testing, form factor development, mater...

The CDMO Division of KD Pharma offer well-established experience in the chemical functionalization of custom and designer polymers. We are specialized in polymer production used in sensitive applications, where a high level of confidence in production consistency, regulatory compliance and technical perfor...

SUPPORT SERVICES FOR OUR CONTRACTED CUSTOMERS • Analytical Development • Validation Support • Regulatory Support • Clinical Supply Services

We like to get involved right from the start of a development project and work closely together with our clients and partners on transforming the idea into a product with a solid and commercially viable target product profile (TPP). We set the bar high but always work step by step with a clear focus on...

• Cytotoxic Injection (Liquid , Lyophilized) • ONCOLOGY  • CYTOTOXIC API • EU GMP  • JGMP (Japan) • KGMP (Korea) • PIC/S

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

Through Recipharm Analytical Solutions™, we support customers with stand-alone analytical requirements. Our analytical development team has experience from developing hundreds of analytical methods every year, supporting development of formulations ranging from powder in capsules and IV solutions to ER tab...

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 materia...

Lomapharm GmbH provides wide range of services which includes development service. It provides the whole range of control services - from raw material testing to stability testing according to GMP and ICH regulations. One of the main areas of competence and experience is also available for galenic dev...

Famar R&D is offering a complete set of Contract Development services.

• Formulation and process development for Rx, Gx, OTC, Cosmetics (Solids, Semi-solids /liquids dosage forms, Sterile liquids & Lyophilized powders) and Medical Devices • Analytical methods development and validation&nbs...

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

GALENIC DEVELOPMENT
• Preformulation studies.
• Design and galenic develop...