In today’s fast-paced pharmaceutical landscape, reliable analytical support is critical to ensuring quality, compliance, and speed to market. Scientech delivers comprehensive analytical services designed to meet the evolving needs of contract manufacturing organizations and pharmaceutical companies.

End-to-End Analytical Capabilities

From early-stage development to commercial release, our laboratory provides accurate, timely, and regulatory-compliant data on the following:

•Method Development & Validation

Tailored analytical methods aligned with U.S. Food and Drug Administration and International Council for Harmonization guidelines.

•Stability Studies

Comprehensive programs supporting IND, NDA, and ANDA filings.

•Impurity Profiling

Advanced techniques to identify, quantify, and control impurities including Nitrosamines.

•Elemental Impurity Analysis (ICP-MS )

Sensitive, ICH Q3D and USP compliant testing for heavy metals and elemental impurities.

•Extractables & Leachables (E&L)

Risk-based studies to support product safety and regulatory submissions.

•Compendial & Wet Chemistry Testing

Full support for United States Pharmacopeia and global pharmacopeial requirements.

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Why Scientech?

•Trusted by CMOs/CDMOs and Pharma Companies

Flexible solutions that integrate seamlessly into your development and manufacturing workflows.

•Regulatory Confidence

FDA cGMP-compliant data generated to meet stringent regulatory expectations.

•Advanced Instrumentation

State-of-the-art platforms ensuring precision and reliability.

•Speed & Responsiveness

Fast turnaround times to keep your projects on track.

Your Analytical Partner from Development to Commercialization

Whether you are scaling up manufacturing, addressing regulatory requirements, or troubleshooting analytical challenges, Scientech provides the expertise and reliability you need to succeed.

Let us Collaborate

Partner with Scientech to strengthen your analytical capabilities and accelerate your path to market.

Contact us at info@scientech-labs.com today to discuss your project needs and discover how we can support your success.

Scientech Laboratories is an FDA cGMP-compliant and ISO 17025 accredited analytical services business that has been family-owned and operated for 45 years. We support the Pharmaceutical, OTC drug, Dietary Supplement, and Cosmetics industries with potency release testing, impurity profiling, heavy metals, nitrosamines, extractables & leachables, microbiology, stability studies and much more.

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