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Analytical Services

Providing purpose-built solutions for drug development programs, Sharp’s state-of-the-art laboratory supports drug product analytical testing across all phases of clinical development.

Our services:

We offer analytical services at the same site as formulation development, providing a streamlined approach to get your product ready for clinical trials.

Our analytical testing capabilities

Excipient/Raw Material Release Testing: Ensure the integrity of your pharmaceutical suppliers with comprehensive analysis of raw materials, including identity, purity and other quality assessments.

In-process Testing: Support process control and optimization with real-time monitoring of critical quality attributes (CQAs) during the manufacturing process.

QC Release Testing: Confirm the quality, potency and regulatory compliance of drug product batches.

Stability Testing: Determine the shelf life, retest date and storage conditions of your drug product with ICH-compliant long-term, intermediate and accelerated stability testing.

Method Development, Validation, USP Verification, and Transfer: Develop and validate the customized analytical procedures for your product.

Impurity Profiling: Ensure product safety and purity by identifying and quantifying impurities, including degradation products and residual solvents

Dissolution Testing: Understand drug product bioavailability and efficacy by evaluating release rate and dissolution profiles.

Trust Sharp with your analytical testing

We understand the importance of analytical testing. That’s why we provide analytical services and formulation development at the same site. Nothing else is needed to take your innovation straight for Phase I in as little as four weeks. 

Using our expertise, state-of-the-art facilities and knowledge of regulatory compliance, we can ensure the quality, safety and efficacy of your formulations. We work closely with you, aligning our analytical testing services with formulation development, delivering accurate and reliable results to the shortest possible timelines.

With Sharp, you get a partnership shaped around you. We are committed to protecting your innovation and supporting you to the next stop on your journey, clinical trials.

Clinical Services Inquiry

Would you like to find out more about our clinical services? Fill the form below so we know what area you’re interested in and we’ll be very happy to help.

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Contact Rob Feltz

To find out more about how Sharp Analytical Services can support your next project, please contact: Robert Feltz, Director of Analytical and Formulation Services

Trusted by many

“The people at Sharp are collaborative, responsive and always willing to accommodate our needs, and this is something to be admired. If they say they can do something, they will deliver no matter what – ultimately, their success is our success, and vice versa.

Sr Quality Supplier Manager, Top 10 Pharmaceutical Company

“Sharp’s responsiveness and flexibility are truly gold standard. Their dedication to the core values of quality and service allows for a true partnership and success in getting our product to patients in need.

External Manufacturing, Top Mid-size Pharma Company

“Sharp is an exceptional partner in the packaging CMO space. They have a dedicated launch team which is unique and a huge benefit vs. having the project lead that handles commercial business also manage the launches. Launches can be very time consuming and they can focus on these activities vs. having to also manage the commercial side.

Top 10 Pharmaceutical Company
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