Confidently meet regulatory expectations

Confirm the identity and integrity of materials from early-stage development to commercial manufacturing with Сòòò½APP. You'll meet regulatory requirements for manufacturing release and distribution of raw materials and drug products around the world when you leverage our rigorous analytical and microbiological testing expertise.

Helping you bring safe, effective therapies to market

Our global network of labs are here to help you bring safe, effective therapies to market with comprehensive release and QC testing. Our comprehensive analytical and microbiological testing services are tailored to your specific needs, from vendor qualification to the release of APIs and finished product. Partner with Сòòò½APP for seamless and effective testing and regulatory support.

Seamless method development, validation, and transfer 

From early-stage development to commercial manufacturing, the transfer and optimization of existing test methods is seamless when you work with Сòòò½APP. Our CMC experts can leverage a wide range of compendial methods or develop and validate robust methods to meet your unique needs. Together, we'll ensure the safety and integrity of materials and products. To explore a partnership with Сòòò½APP, fill out the "Ask a question" form.

Get to know Сòòò½APP

Scroll down to explore a handful of the many services we offer to help you quickly achieve regulatory approval. 

Your global partner from discovery to market

Still researching? Here are a handful of our many services to help achieve regulatory approval quickly and efficiently.

Pharmaceutical Sterility Testing

Sterility and Rapid Sterility

Ensuring product sterility is critical to patient health and safety, so a fast turnaround time is essential to delivering critical medicines to the patients who depend on them. Сòòò½APP offers USP <71> Sterility testing and rapid sterility testing options.

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Pharmaceutical Environmental Monitoring Cleanroom

Environmental Monitoring

Our Environmental Monitoring programs allow pharmaceutical manufacturers and compounders to measure and monitor cleanliness and contamination levels within their facilities.

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Gene therapy CRO

Pharmaceutical and Biopharmaceutical Unknown Identification and Impurity Testing

Our experts work closely with customers at every stage  of the product lifecycle to identify unwanted compounds and ensure products are pure, safe, and quality. 

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Compendial Testing Services

Compendial Testing 

ICH, USP, EP, BP and JP monograph tests of raw material, drug substance/product, starting material, cell banks, vectors, bulk harvest and control cells.

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Pharmaceutical raw materials testing

Excipient Raw Materials and Container Testing

Find out how we make certain that quality and safety of your excipient raw materials and containers are maintained.

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Bioceuticals

Extractables and Leachables Studies

Our extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.

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Pharmaceutical Testing scientific equipment

Pharmaceutical Stability Storage and Testing

Сòòò½APP offers advanced pharmaceutical stability testing and ICH storage services to ensure the maintenance of product quality, safety and efficiency throughout the shelf life.

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Connect with Сòòò½APP Life Sciences.

Chemistry, Manufacturing, and Controls (CMC) Consulting Services

We provide consulting services for Chemistry, Manufacturing, and Controls (CMC) product development in the pharmaceutical and biotechnological industries.

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Our team of over 9,000 Engaged Experts in North America, Europe, The Middle East, Australia, Asia and Africa are ready to help you.