Development & Validation of Analytical Methods

•Development and validation of analytical methods to ensure accurate quantification, purity assessment, and impurity profiling. 

•Characterization of raw materials, intermediates, and final APIs using techniques such as HPLC, GC, MS, NMR, and XRPD. 

•Stability studies and fo...

Physico-Chemical testing
- General identification (TLC, HPLC)
- Assay (UV/VIS, HPLC-UV, GC-FID, LC-MS/MS) and dosage uniformity
- Related substances identification and quantification (HPLC-UV, GC-FID, LC-MS/MS)
- Physical determinations (pH, viscosity, density)
- Moisture...

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...

Services for the development of inhalation drugs: Our team have over 30 years of experience supporting our clients' product development for orally inhaled or nasal drug products (OINDP). This includes formulation, stability, testing, product performance testing, in vitro bioequivalence studies, CMC...

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.

Polymer-based dosage forms continuously administer the drug to the patient for an extended period, varying from weeks to years. These controlled-release products are very suitable for specific indications, patient populations, and drugs due to the long duration of action, avoidance of first-pass metabolism...

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...

KD Pharma’s professional expertise, state-of-the-art assets and proven track record in regulatory compliance allow us to become your preferred CDMO solutions partner.

Your Agile Experts
• Responsive to our customers’ needs in a more dynamic customer-centric way • Adaptive to the most diverse re...

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)

Analytical services 

In addition to the basic product quality control, the following connected services are offered, which are required throughout the product development or before the market launch of the respective products:

 

GMP for excipients, risk assessment...

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...