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Capability

regulatory submission support

Suppliers
2
States & provinces
2
Countries
1

2 regulatory submission support suppliers across 2 states and provinces in 1 country. Profiles show capabilities, materials, certifications, and facility locations so you can compare shops and build a shortlist.

Suppliers

CMC PHARMACEUTICALS INC

SOLON, OH

CMC Pharma is a small molecule contract development and manufacturing organization (CDMO) providing end-to-end CMC (Chemistry, Manufacturing, and Controls) drug development services. It offers formulation and process development, analytical chemistry, ICH stability and compatibility testing, method transfer, scale-up and tech transfer, CMO selection and oversight, and integrated regulatory support for IND/NDA submissions. The company operates cGMP laboratories and a pilot plant for non-GMP small batch production but does not own a commercial GMP manufact

analytical method development and validationcGMP complianceCMO management and oversightcompatibility assessmentsdissolution studiesforced degradation studiesformulation developmentICH stability testingmethod transferpilot plant small batch productionprocess developmentrelease testingScale uptech transfer

Compiled from public sources

INSTEM LSS NORTH AMERICA LTD

BOSTON, MA

Instem is a supplier of SaaS platforms for the global life sciences community, spanning In Silico & Data Insights, Study Management, Regulatory Submission, and Clinical Trial Analytics. Its applications help life science and healthcare organizations capture, analyze, and submit regulatory data, supporting data-driven decision making. The company states it helps over 700 clients ensure global compliance.

clinical trial analyticsconsulting servicesdata managementpredictive analyticsSaaS software platformsSEND conversion and validation

Compiled from public sources

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