CMC IND/BLA Roadmap, Strategy
& Operational Readiness Assessment
– Partner with client to develop IND/ BLA CMC Roadmap.
– Provide technical writing and authoring of IND/BLA components.

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Quality Control and Analytical Development
– Assess test method lifecycle.
– Establish stability program.
– Develop method transfer protocol and provide oversight.
– Develop & implement Quality Technical Agreements for quality control laboratories.
– Perform Methods gap assessment & Remediation strategy.

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Quality Systems
- Assess, develop, implement  and apply continuous improvement to Quality Management Systems.
- Author Policies and SOP's for all areas supporting GXP activities.

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Quality Operations
- Provide person in plant.
- Provide qualified person.
- Provide Quality oversight of CDMO and CTL's.
- Perform review of Batch records.
- Perform and or approve investigations.

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Quality Engineering and Validation
- Author Validation Master Plan.
- Perform equipment validation.
- Perform risk assessment, identify controls,
mitigations and establish a risk register.

Regulatory Inspection Preparation and Responses
- Partner with client to develop roadmap for pre-approval
inspection preparation and/or regulatory inspections prior,
during and post inspections.
- Partner with client to author or evaluate
regulatory inspection responses.
- Lead mock inspections (FDA, BIMO, Health Canada,
EMA, MHRA, TGA and various BoH's authorities.

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Vendor Audits

- Perform vendor/supplier /CMO audits.
- Establish vendor/supplier quality audit programs.

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Quality Agreements
Partner with client to author Suppliers/CDMO's
/Service Quality and Technical agreements.

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Interim Leadership and Mentoring

- Provide interim leadership roles coverage.
- Provide mentoring & coaching in different
roles to the Quality Organization.

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