Development & Validation of Analytical Methods

ESTEVE CDMO supports high-potency small-molecule programs from process and analytical development through cGMP manufacturing and commercial supply.

Our dedicated Highly Potent API capabilities include a specialized R&D laboratory in Barcelona and an industrial manufacturing sites, designed t...

TP&C provides tailored formulation development services for pharmaceutical, OTC and dermo-cosmetic products, adapting each project to target performance, regulatory needs and manufacturing constraints. From concept to scale-up, the R&D teams support partners with formulation optimization, stability...

GMP analyticsQuality control of raw materials, excipients, active pharmaceutical ingredients (APIs), and finished medicinal products
Batch release (EU retest)
Method validation, verification, and transfer
Biopharmaceutical studies
Human and veterinary sectors

Our services for clinical trial batches:
• Manufacturing an tailor-made primary, secondary and tertiary packagingLabelling of primary, secondary and tertiary packaging • Customised labelling incl. blinding/randomisation • IMPD WritingDevelopment and packaging of individual patient kits • Release and...

As a Managed Service Provider, Catalyx delivers dedicated GMP-expert teams to execute defined scopes of work or support critical functions within a client’s business. Led by an experienced team lead, our solutions ensure full alignment with client expectations while providing managed, flexible, and scalabl...

Concerned about nitrosamine impurities in your research? Look no further than Simson Pharma, your trusted source for high-quality nitrosamine impurities at unbeatable prices. Nitrosamine impurities are closely monitored due to their potential health risks, and having accurate standards is vital for an...

Alcami offers fully-integrated analytical method development, method validation and testing solutions for raw materials, API/BDS and Drug Product.Built on a foundation of comprehensive analytical services for pharmaceuticals including biologics, our advanced laboratories and experienced scientist...

Lipid Portfolio

Omega-3 APIs

·        Largest producer of omega-3 APIs worldwide

·        Ultra-high purity: EPA up to 99%, DHA up to 95%, tailored ratios
...

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...

ChemCon's analytics team takes care of your inquiries if you are looking for ICH-compliant quality control, GMP validation, release analysis, impurity determination, reference standards or answers to other analytical queries. Close, outcome-oriented communication is the key to a successful partnership: We ...

Coriolis Pharma offers release testing services to ensure that drug products meet their intended target product profile, safety, efficacy, and regulatory standards. Our analytical offerings include both compendial and custom methods for purity, identity, potency, particle and aggregate analysis, polysorbat...

Analytical methods development & validation: We apply a broad range of analytical technologies - including chromatography, mass spectrometry, spectroscopy, biophysical and bioanalytical techniques - across diverse products and methods - to ensure every method is fit for its intended purpose.
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PLD offers formulation, process and analytical development support of new or existing products using the most current and effective active ingredients and delivery systems. Our team of scientists bring decades of pre-formulation development expertise to your products, combined with the knowledge of how to ...

•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...

Clearsynth is a globally trusted partner for reference standards and research chemicals. We offer over 3,000 nitrosamine impurities, 5,000+ stable isotopes, and 10,000+ drug impurities, encompassing a vast portfolio of more than 325,000 products serving various industries, including pharmaceuticals, clinic...

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.

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...

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