Development & Validation of Analytical Methods

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

Identification and quantification of genotoxic impurities: To reduce drug safety and quality risks, diagnosing and limiting genotoxic impurities early on in drug development can reduce risk associated with genotoxic impurities. With the implementation of increasingly stringent regulations for impurity l...

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...

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.

With a team of experienced scientists and a robust toolbox of analytical techniques, 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 entire spectrum of development and manuf...

Method Development and validation
Stability Studies
European testing & batch certification

Analytical Services: QC Chem/Microbio, stability, etc.

To successfully develop and manufacture your polymer-based delivery systems, like implants and intra-vaginal rings, we have advanced extrusion capabilities in Malmö (Sweden) and Putnam (US Connecticut). The US site is also a center of expertise for Hot Melt Extrusion (HME).

HME improves the bioa...

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...

• 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)

Famar R&D is offering a complete set of Contract Development services.

• Formulation and process development for Rx, Gx, OTC, Cosmetics (Solids, Semi-solids /liquids dosage forms, Sterile liquids & Lyophilized powders) and Medical Devices • Analytical methods development and validation&nbs...

TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract Manufacturing

GALENIC DEVELOPMENT
• Preformulation studies.
• Design and galenic develop...

CARBOGEN AMCIS has a DNA in API development, stretching back over 30 years. Our API development teams are selected for their passion for science and experience in the application of phase-appropriate efforts to solve challenging chemistry issues. From taking a promising molecule from our clients' medi...

Avéma 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 t...

We have extensive experience in solving complex formulation challenges. Our experts can apply our extensive range of proprietary technologies for immediate (IR) and modified (MR) / sustained, slow (SR) / controlled (CR) / extended (XR, ER) / pulsed / timed release as well as enteric and gastro reten...

With extensive, state-of-the-art analytical testing facilities and equipment, our expert teams are able to develop and validate the methodologies required to characterise inhaled delivery platforms, especially DPI, pMDI and nebulised products.

To ensure seamless support for your development...

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:...

Method development and validation can be a complex story, and Oasis Test House has systematic procedures to guide its Customers through the process. Our team team of dedicated and qualified personnel are competent to develop methods and validate them as per ICH Guidelines.  Before we begin a ...