Compliance You Can Trust: Your Partner in Reliable Analytical Testing

In today’s highly regulated pharmaceutical and healthcare environment, analytical testing laboratories must do more than generate data—they must demonstrate compliance, integrity, and reliability at every step. Scientech Laboratories is built on the foundation of regulatory excellence, scientific rigor, and quality-driven operations.

Built to Meet Global Regulatory Expectations

Scientech Labs operates to the highest global regulatory and quality standards, ensuring data integrity, consumer safety, and regulatory compliance at every stage of testing.

✔ FDA cGMP Compliant: Fully compliant with U.S. FDA Current Good Manufacturing Practices (21 CFR Parts 210, 211, and 58).

✔ ISO/IEC 17025 Accredited: Demonstrating technical competence and reliability of analytical results.

✔ ICH Guidelines Compliance: Testing conducted in accordance with ICH requirements.

✔ DEA Registered: Authorized handling and testing of controlled substances (Schedules II to V).

✔ USP / Ph. Eur. / BP and EPA Aligned Methods: Test methods developed and validated per recognized pharmacopeial and regulatory standards

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Data Integrity Is Not Optional—It’s Our Standard

Regulators expect data that is accurate, complete, contemporaneous, and traceable.   Scientech ensures:

• Secure, audit-ready data systems.

• Controlled access to instruments and software.

• Proper documentation and review practices.

• Strong change control and investigation processes.

Our clients can rely on results that are defensible, reproducible, and ready for inspection.

Safety, Quality, and Compliance—Working Together

A compliant lab is a safe lab. Scientech maintains:

• OSHA-compliant safety programs.

• Proper chemical handling and waste disposal.

• Qualified equipment and controlled environments.

• Routine internal audits and continuous improvement.

This integrated approach protects personnel by minimizing safety risks, preserves sample integrity through controlled and compliant practices, and strengthens regulatory submissions by ensuring data quality, traceability, and adherence to applicable guidelines.

Inspection-Ready, Always

Whether supporting regulatory filings, stability studies, method validation, or routine QC testing, our laboratory is maintained in a constant state of inspection readiness. We do not prepare for audits—we operate as if one could happen any day.

Your Compliance Partner

Choosing an analytical testing lab is a critical compliance decision. Partner with a laboratory that understands regulatory expectations, values quality, and delivers data you can trust—every time.

Scientech Labs is here to compliantly meet your analytical testing needs for potency, impurity profiling, heavy metals, nitrosamines, extractables & leachables, microbiology, stability studies and much more. Please reach out to us for a compliance and testing consultation at info@scientech-labs.com.

Compliance is not just a requirement. It is our commitment.

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