Analytical Development
Comprehensive Analytical Testing Services
Making informed, critical decisions about your drug product development process is crucial to preparing CMC data to meet regulatory requirements. Our analytical testing services team has a robust toolbox of analytical techniques to support the entire spectrum of pharmaceutical development and clinical manufacturing.
Analytical Services for Pharmaceutical Development
Our laboratory team delivers comprehensive analytical solutions that cover the full range of development and clinical manufacturing. We can further support your research by recommending phase-appropriate analyses, ensuring product safety, enhancing manufacturing efficiency, and providing the necessary CMC data for regulatory submission across the following processes:
- Development and validation of analytical techniques
- Analysis of in-process samples
- GMP release at clinical scale and commercial products
- Formulation and process development activities>
Our Suite of Analytical Services
- Technology transfer
- Method feasibility, development, and validation
- Release testing of raw materials, API, and finished products
- Stability assessments aligned with ICH Q1A(R2) guidance for long-term, intermediate, and accelerated conditions
- Compendial testing (USP, Ph. Eur., BP, JP)
State-of-the-Art Analytical Capabilities
Our 3,800-square-foot GMP laboratory, equipped with cutting-edge technology, offers a wide range of analytical techniques to support R&D across various drug product forms, including oral solid dose and inhalation drug products. Our scientists are exceptionally skilled in supporting complex studies across multiple formulation types, ensuring comprehensive expertise regardless of delivery method.
The laboratory’s more extended capabilities include analyzing products requiring special environmental controls for storage, as well as physiochemically hygroscopic, light-sensitive materials and controlled substances.
Why Choose Experic
When selecting a CDMO for your drug product, it’s essential to partner with a company that has deep expertise across various dosage forms, including inhalation, powders, and encapsulation. Our subject matter experts are highly experienced in navigating the complexities and regulatory requirements for each therapeutic area and dosage form, ensuring a seamless transfer of your product from development to clinical manufacturing, no matter the delivery method.
At Experic, we offer the following:
- Extensive expertise in encapsulated oral solid dose and inhalation product development
- Full compliance with 21 CFR Part 211, 21 CFR Part 11, EudraLex Volume 4, and ICH Q10
- Advanced stability testing and environmental controls
- Customized CMC data preparation for regulatory submission
Analytical Service Capabilities
Learn more about the comprehensive analytical services offered at Experic. Our detailed information sheet provides additional information on… Storage Temperatures Analytical Support for Dry Powder Inhalation Products Testing Methods & Equipment
Inhalation Modalities and Formulations
At Experic, we offer the following inhalation modalities and formulations to support your drug product development, from early clinical development to CMC manufacturing.
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Dry Powder Inhalers (DPI)
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Dry Powder Nasal Sprays
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Other Custom Formulations and Delivery Platforms
Specialist Services
Experic offers bespoke development, manufacturing, and clinical packaging, labeling, storage, and distribution services to meet your product's unique needs.