Project scope, budget and timeline development
Contractor management
Problem investigation and resolution

All activities in support of the CMC portions of IND/CTA submissions, from drug substance synthetic route development and optimization, drug substance characterization, dosage form selection and formulation development, through GMP API and clinical trial material manufacture are broken down, budgeted, and aggressive but realistic timelines proposed. Guidance is provided on CRO and CMO proposal development and assessment, budget negotiation, contractor selection, and management of activities to ensure that the overall project timelines are met.

Coordination of Drug Substance characterization studies:

-         Proof of Structure studies for regulatory dossiers/patent applications

-         Preformulation studies, salt form selection

-         Solid State characterization including polymorph screens

Analytical method development and validation for:

-         Drug Substance

-         Clinical dosage form

-         Cleaning verification methods

Stability studies according to ICH guidelines

Specification proposal and justification

Complete support can be provided for all analytical and quality control aspects of CMC development ensuring that studies are conducted according to current industry practice and in compliance with regulatory requirements. This includes definition of required studies, CRO selection, study coordination, validation protocol review and approval, and review of raw data and final study reports.

Coordination of bioanalytical method validation and support for non-clinical and clinical PK studies.

Assistance is provided in CRO selection, bioanalytical method development, method validation protocol review and approval, data and report review and approval, and overall study coordination. Compliance with GLP requirements, industry standards and regulatory guidances is ensured.