Method Development

We offer unparalleled breadth of packaging experience to help our clients deliver safe and effective products to market. Our services encompass consulting, package validation, material qualification and package development. Nelson Labs packaging solutions department has experience with successful valida...

Nelson Labs is a leading provider of sterility assurance test services for medical device, pharmaceutical and tissue manufacturers for both sterile and nonsterile products. Most tests follow United States or European Pharmacopeia (USP or EP) and similar international standards. Medical device standards are...

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.

Our analytical experts know what it takes to bring a pharmaceutical product to the market, from discovery, feasibility to GMP. Having worked with more than 100 unique molecules and even more formulations, we may state that we have faced the most difficult CMC challenges that are involved.
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Take no risk with your analytics when developing new therapeutic monoclonal antibodies. Our analytical teams take advantage of their extensive experience in the analysis of mAbs. Throughout non-clinical and clinical development, our experts provide you with the customised solutions in terms of analytical ...

To meet your analytical needs, Quality Assistance provides you with scientific and technical support for the development of your New Chemical Entities. Our added-value brings together a sound expertise in small molecules analytical development with state-of-the-art facilities and equipment, all o...

Thanks to 35 years’ experience in analytical sciences and all our laboratories on one site (Mass Spectrometry, Physico-chemistry, Cell Biology, MolecularBiology and Microbiology), Quality Assistance covers all the analytical technologies needed to support your drug development process i...

Quality Assistance covers all the analytical technologies needed to support your drug development process: CMC (Quality) studies to be perfomed, including Ab characterisation, development and validation of analytical methods, stability studies and batch testing. For Bioanalysis to be performed in Non-clini...

Presenting Electronic Logbook, complying with 21 CFR Chapter 11 requirements, a simple yet controlled platform for all Pharmaceutical manufacturing to manage logbooks, digitally.

Complying with GMP guidelines, Electronic Logbook provides capability of defining flexible workflow, SOPs on area...

Laboratory Services
Our 30 years of experience and our continual quest for improvement ensure we deliver analytical services of the highest level for active ingredients, excipients, medicinal products and drug-​related products. In addition to developing and validating analytical methods, batch-...

On pure API or in formulation.We offer exploratory as well as QC.
OEL: 50 ng/m3.
Analytical methods listed: XRPD, DSC, TGA, laser PSD, DVS, FT-IR;

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...

At Integrated Analytical Laboratories (IAL), our approach to method development helps reduce bottlenecks and reduces errors. We understand time is of the essence, so IAL provides a consultative approach with our partners to ensure that your new drug product will meet the goals and objectives you a...

Idifarma’s analytical development services include the following activities:
- Solubility studies in different media (organic, aqueous and different PH levels).
- Characterization of the thermal profile and identification of polymorphic forms by DSC.
- Impurities profile characterization. q...

Welch Ghost-Buster column can efficiently adsorb and remove the impurities from the mobile phase to eliminate their interference to the target peaks. 

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...

Neopharm Labs has two distinct validation departments; Chemistry and Microbiology. Each validation department is dedicated to the development, validation, verification, recovery and inter-laboratory transfer of analytical methods. Typical samples include raw materials, API, finished products, cleaning and ...

PMI Bio’s talented Research team provides extensive protein science services that include small projects such as expressing and purifying a single protein to biochemical and biophysical support for multiyear discovery campaigns.  Our experienced team of scientists uses multiple techniques includin...

Speed Laboratory is a QC/QA laboratory that supports both FDA-regulated and non-regulated products and companies, with value, integrity, and commitment. In today’s dynamic marketplace, organizations can be reassured that they will get exceptional laboratory services in the pharmaceutical, consumer goo...

Spark-Lab Chemical Analysis Department performs qualitative and quantitative analyses in response to the needs of, above all, the chemical industry and related sectors. Research is carried out with the use of high-end, qualified measurement equipment. Routine analyses carried out in Spark-Lab me...

Spark-Lab Pharmaceutical Analysis Department performs routine analyses with a special emphasis on determination of excipients, such as:

• Quantitative determination of sorbitol, glycerol, maltitol, mannitol in liquid forms based on our own method; • Quantitative determination of glucos...

The Pharmaceutical Analyses Department of Spark-Lab conducts research and development work in cooperation with pharmaceutical and cosmetics manufacturing plants. The Laboratory provides services through its highly skilled personnel and state-of-the-art equipment at the initial phase of works on a g...

Inkemia IUCT Group offers a wide range of services which includes analytical development and validation for pharmaceuticals. Features: it has physico-chemical methods which includes separation and characterization of impurities and degradation products; set up and optimization of methods according to speci...

Inkemia IUCT Group offers a wide range of services which includes isolation and characterization of impurities. Features: it includes development and validation of analytical methods for determining related substances; impurity profiling; getting forced degradation impurities; isolation and purification of...

Evaluation of industrial and environmental risks, product protection

NEWS: Hot Melt Extruction is the newest technology now available at Midas Pharma.
Midas Pharma Polska Sp. z.o.o. provides a complete range of services for developing and manufacturing finished drug products, and we have expertise and experience to overcome challenging galenical or analytical hurdles. It...