Dahlia Life Science Medical Consulting

QUALITY COMPLIANCE & REGULATORY

Interested in seeing what we can do for you? Call or email us to start the conversation.
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 the 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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Pharma manufacturing vendor audits display graphic.
Vendor & Contract Manufacturing 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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Dahlia Pharma Biotherapeutics Advisors Science

QUALITY COMPLIANCE & REGULATORY

Interested in seeing what we can do for you? Call or email us to start the conversation.
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.

LEARN MORE
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.

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

LEARN MORE
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.

LEARN MORE
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.

LEARN MORE
Pharma manufacturing vendor audits display graphic.
Vendor Audits

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

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

LEARN MORE
Interim Leadership and Mentoring

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

LEARN MORE
Dahlia Pharma Biotherapeutics Advisors Science