Development & Validation of Analytical Methods

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...

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

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
...

ESTEVE CDMO supports highly potent small-molecule API programmes from fit-for-phase process and analytical development through cGMP manufacturing and commercial supply.

Our dedicated HPAPI capabilities combine specialized R&D, cGMP manufacturing and quality control infrastructure designed to...

Over 400 developed recipes, 
including over 30 medical devices in various classes and indications,
in 20 pharmaceutical forms - 
everything starts in the Gofarm's R&D Laboratory.



In Gofarm's R&D Laboratory our and our clients' ideas take real shapes...

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...

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...

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 ...

Method Development and validation
Stability Studies
European testing & batch certification

We provide support in developing analytical methods using UV-VIS spectroscopy, High-Performance Liquid Chromatography, and Ultra-Performance Liquid Chromatography for the quantification of small molecules and biomolecules. Our particular strength lies in creating robust methods for samples in complex disso...

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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Lambda provides regulated bioanalytical support for large molecules, biologics and biosimilars across clinical development. Capabilities include large-molecule PK analysis, anti-drug antibody assessment, neutralizing antibody testing, pharmacodynamic biomarkers, functional bioassays, immunogenicity assessm...

Characterization & Comparability,​ including method development & troubleshooting​-Deep expertise to assess the physical, chemical, and performance properties of your ADC, with tailored packages to meet the specific needs of each molecule.​

Release Testing & Stability Studies,​ inclu...

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...

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...

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

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 ...