Analytical Testing Services
Unparalleled quality
at every phase, every scale
Our analytical services cater to the development and testing of small molecule APIs, pharmaceutical intermediates, drug substances and drug products, AAV and lentiviral vectors, plasmid DNA, and cell therapies, as well as vaccines, biologics, antibody-drug conjugates, and other advanced therapies.
Explore Our Analytical Services Offerings
Analytical Testing Programs
Our analytical testing programs provide comprehensive solutions for raw material, excipient, and extractables/leachables testing, stability testing, drug substance and drug product release testing, nitrosamine and genotoxic impurities testing, and safety testing, ensuring the quality and safety of your compound or drug product.
Small Molecule Analytical Services
With deep expertise and a full portfolio of cutting-edge instrumentation, we offer end-to-end support in developing and executing the right analytical testing strategy for small molecule APIs, drug products and intermediates, high-potency APIs (HPAPIs), and controlled substances.
Technology Platforms
Advanced technology platforms including continuous processing, high potency chemistry, and chromatographic separations to drive efficient and scalable API production.
Cell & Gene Therapy Analytical Services
Whether you’re working with another manufacturer or partnering with us to produce your advanced therapy, SK pharmteco can support analytical development, method transfer, qualification, and validation, as well as full CGMP testing capabilities for drug substance and drug product release testing.
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Relevant Resources
Analytical Testing Services FAQs
With countless options available, selecting a CTO/CDMO partner for analytical testing services can be a difficult task. There are a number of key factors to consider when evaluating potential providers. First, consider the breadth of expertise within the organization, as well as its proven track record in analytical development and validation relevant to your modality. Look for a CTO/CDMO equipped with a broad portfolio of cutting-edge instrumentation and scientific expertise to handle a diverse range of analytical tests. Facilities should also have adequate capacity to provide timely service for projects of every size. Regulatory compliance is non-negotiable — ensure the CTO/CDMO is well-versed in relevant guidelines to guarantee high-quality data and comprehensive documentation that can support regulatory submissions. Effective communication, transparency, and project management are also vital for smooth collaboration and timely delivery of results. Ultimately, choose a CTO/CDMO partner that not only meets technical requirements but also shares your commitment to quality, taking a vested interest in your success.
CGMP compliance ensures that the pharmaceutical products being tested meet the highest safety and quality standards according to Current Good Manufacturing Practices, which is essential for regulatory approval and market acceptance. Global regulatory authorities such as the FDA and EMA require CGMP compliance for drugmakers, making it a legal and ethical obligation. A CDMO’s dedication to CGMP compliance reflects their capacity to provide consistent and reliable analytical results, ensuring accuracy and reproducibility in their testing processes and regulatory support for clients across the drug development and manufacturing spectrum. SK pharmteco’s facilities are equipped to handle analytical development and testing for CGMP APIs, intermediates, and a variety of drug product formulations.
Backed by an established track record of compliance with dynamic regulatory requirements, SK pharmteco’s comprehensive analytical capabilities can support regulatory submissions throughout drug development and commercialization. Our expert team can help partners develop and validate analytical methods to provide essential data and prepare documentation for regulatory submissions, guided by knowledge of current, phase-specific regulatory requirements. Whether a partner is building a regulatory strategy from the ground up or seeking CGMP-compliant contract testing services for a commercial drug product, SK pharmteco can generate accurate, reliable data necessary to demonstrate safety, efficacy, and quality in regulatory submissions.
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