Method Development

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

We offer the development and validation of test methods for identity testing, assay, purity testing and in vitro dissolution for active ingredients, excipients, intermediates, finished products and substance-based medical devices. Our method development and method validation are in accordance wit...

LabAnalysis is a family owned CRO offering innovative and reliable solutions to Quality Controls andResearch and Development Departments. Customer Care and Commitment to Quality are the driving forcesfor our continuous and sustainable growth with a proven track record of long last business partnershipsarou...

From early development, including mammalian cell line development, cell culture development, and process development, through to pre-clinical production and commercial supply, Patheon by Thermo Fisher Scientific provides CDMO services for protein-based biologic therapeutics. Patheon offers biotech and ...

Chemical Development Solutions provides a convenient, single-site distribution of infrastructure, thereby delivering a seamless and innovative transition of solutions from lab to pilot plant and bulk manufacturing, with speed and quality.

We ensure quality in the process during the design an...

Our automated CCI testers for vials, syringes, ampoules, blow-fill-seal containers, IV bags and other pharmaceutical packaging use the latest generation of differential pressure testing or headspace analysis procedures allowing a highly sensitive and robust measurement.

Highlights: • Indus...

Innovation & Formulation: We offer pharmaceutical R&D, feasibility studies, proof-of-concept, formulation development and analytical method development for multiple dosage forms such as solids, semi-solids, liquids, oral films, and transdermal patches. We can work with over 30 pharma technologies f...

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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• Control of pharma samples solid state : Identification and quantification of solid state, method development and validation, routine QC. • Analytical techniques available : XRPD, DSC, TGA, DVS, Laser PSD, FTIR, IDR. • All analyses are applicable to toxic samples down to : 50 n...

From the laboratory to the industry. 

The key to a correct Scale-Up and Transfer of lyophilization processes is the knowledge of the developed product, as well as the control of the process and the capabilities of the final equipment.

XEDEV provides a broad range of analytical tools including : • Solid state analysis: mDSC, XRPD, PLM, TGA, FTIR, RAMAN • Powder characterisation : SEM, PSD (both wet and dry), flowability • Tablet characterisation : friability, disintegration, hardness, dissolution • Residual solvent determination :...

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

Aurigene Pharmaceutical Services offers a wide range of chemical development services for pharmaceutical, agrochemicals, fine chemicals and animal health industry. We support the development of Key Starting Materials (KSM) / Registered Starting Materials (RSM), advance intermediates and APIs from the ...

Our Formulation Scientists and Process Engineers are experts in poorly soluble compounds and high containment operations. Our formulation development lab and pilot plant suites are specifically designed for high containment and outfitted with cGMP matching technologies. We follow a data driven approach to ...

Neotron Pharma is able to offer you a research and development service. The research and development laboratory, operating under the ISO regime, will be able to develop customized methods for the customer in faster times and with lower costs. Subsequently, the customer will be able to validate the GMP meth...

Ultisil Series HPLC Columns based on Ultra Pure (purity>99.999%) spherical and totally porous silica, adopted unique bonding chemistry and proprietary surface modification technique, which provide excellent peak shape, column efficiency and exceptional lot-to-lot reproducibility. Ultisil Column is the b...

The Pharma Servicdes / Lichtenheldt development Department (LDS) accompanies and advises our customers from product idea through galenic development and through the registration into the routine production. For product development and scale up Lichtenheldt has its own dedicated staff and laboratories, ...

We support early-phase and scale-up development for complex, non-sterile formulations. Our team ensures your product is ready for manufacturing, aligned with regulatory expectations, and optimized for commercial production.

With deep expertise in navigating regulatory landsca...

At PLD Pharma Services our analytical testing lab is also a development lab where we develop and optimize analytical methods that are robust and QC-friendly. We ensure that methods are efficient, reproducible, and aligned with both regulatory expectations and commercial manufacturing needs. 
q...

Manufacturing facilities and processes can be a primary source of product contamination. Nelson Labs offers a range of services to assess these manufacturing environmental conditions, in addition to water system validations, raw material screening and residual manufacturing material tests.