Analytical R&D

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Scienico Healthcare has been providing analytical expertise and laboratory services for several years now. We provide analytical method development, validation and testing for your topical and specialty semi-solid dosage form. Our scientists have expertise in analyzing complex semi-solid matrices to support development, informal and ICH stability studies, and release of clinical trial materials.

Our Analytical Services Include

Analytical Method Development

Phase- Specification Analytical method development, validation and testing for ANDA, NDA & OTCs

Cleaning Validation

Cleaning methods for manufacturing equipment.

Batch/lot release
testing

Batch/lot release testing for APIs and finished drug products including method transfers.

Stability

Stability testing (to support formulation development, preclinical, clinical and commercial activities)

Global Regulatory Compliance

Compendial testing to meet various global regulatory needs, such as USP, EP, JP, MHRA, TGA, ANVISA, etc.

Analytical Instrumentation

Scienico Healthcare has state-of-the-art equipment in place for the testing and analysis of semi-solid products. The lab capabilities continue to grow with customer and business needs.

HPLC / UPLC

Our team works closely with each client to not only meet their specific needs in the most efficient way possible, but they also strive to exceed those needs by anticipating obstacles and formulating solutions. The vast array of specialties encompassed in our services for topical products include method development and validation, as well as planning and execution of stability studies for both R&D and GMP purposes. We meticulously gather data throughout the analytical process to ensure reliable, specific, and robust results for analytical release, validation, and method development. We also have the capability to execute method transfers, refining the existing process to meet and/or exceed client and global regulatory needs.