Consulting Services
Subject Matter Expert (SME) Consulting Services
We have experience with:
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All Biologics Manufacturing Process Development and Commercialization (Therapeutic Proteins, Vaccines, Immunotherapies, etc.)
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Upstream and Downstream Processing with All Cell Line Hosts (Bacterial, Yeast, Mammalian, etc.)
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Authoring of all Regulatory Filings for Biologics
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Regulatory Compliance Assessments
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Clinical Data and Regulatory Submission Management
1
Process Validation Stage 1
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Process Validation Master Plan Authoring and Review,
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Critical Quality Attribute (CQA) Determination,
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Key Process Attribute (KPA) Determination,
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Critical Process Parameter (CPP) Determination,
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Key Operating Parameter (KOP) Determination,
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Process Development and Characterization,
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Master Cell Bank (MCB)/Working Cell Bank (WCB) Characterization and Stability Qualification,
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Failure Modes and Effect Analysis (FMEA),
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Leachable/Extractable Risk Evaluation,
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Raw Material Risk Evaluation,
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Process Control Strategy Authoring and Review.
2
Process Validation Stage 2
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Process Performance Qualification (PPQ) Readiness Planning and Deployment (Right First-time),
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Process Validation Study Design and Templating,
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Process Performance Qualification (PPQ) Protocol and Report Authoring and Review (Upstream and Downstream Processes),
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Design and Authoring of Misc. Qualifications:
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Fermentation/Cell Culture Media Hold Qual.,
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Solution/Buffer Hold Qual.,
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Equipment or Product Pool Mixing Studies,
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Product Re-filtration Qual.,
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Intermediate (In-Process Pool) Hold Qual.,
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Leachables/Extractables Assessment,
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Drug substance filter validation,
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Drug Substance Homogeneity Qual.,
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Container Closure Integrity Testing,
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Chromatography Resin Re-use Qual.,
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TFF or UF/DF Membrane Re-use Qual.,
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Transport Validation (MCB/WCB, Analytical Samples, BDS, DP)
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Product Comparability Assessments,
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Pre-approval Inspection (PAI) Preparation and Compliance Review,
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Authoring and Review of Drug Substance BLA/NDA (3.2.S.2), MAA, IND, IMPD, and APR Sections,
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Due Diligence Review: Contract Manufacturing Organizations (CMO), Partnership Organizations and Acquisitions,
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Regulatory Compliance Assessments,
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Auditing.
3
Process Validation Stage 3
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Continued Process Verification (CPV),
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Non-conformance Investigation,
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Corrective-action/Preventative-action (CAPA) Implementation,
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Validation Maintenance,
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Annual Product Review Assessment (APR).
Quality System Design Services
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Critical Quality Attribute (CQA) Determination Policies,
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Global Process Validation System Review, Development, and Harmonization,
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Process Validation Stages (1, 2, and 3) Policies,
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Process Validation Core Requirements,
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Application of FDA/ICH Regulatory Standards and Industry Best Practices for Process Validation,
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Validation Maintenance Policies.
On-site Consulting Training
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Introduction to Process Validation: Basic Strategies and Requirements,
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Chromatography Resin and UF/DF Membrane Re-use Validation,
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Intermediate Pool Hold Validation,
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Risk Assessment of Filter and Component Leachables/Extractables,
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Media, Buffer, and Solution Hold Validation,
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Risk Assessment of Microbial/Endotoxin Ingress,
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Process Performance Qualification Readiness,
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Determination of Critical Quality Attributes by Risk Assessment,
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Determination of High-risk Raw Materials by Risk Assessment,
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Introduction to Process Characterization: Concepts and Strategies,
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Re-filtration Validation,
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Transport Validation.
On-site Consulting Training
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Introduction to Process Validation: Basic Strategies and Requirements,
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Chromatography Resin and UF/DF Membrane Re-use Validation,
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Intermediate Pool Hold Validation,
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Risk Assessment of Filter and Component Leachables/Extractables,
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Media, Buffer, and Solution Hold Validation,
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Risk Assessment of Microbial/Endotoxin Ingress,
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Process Performance Qualification Readiness,
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Determination of Critical Quality Attributes by Risk Assessment,
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Determination of High-risk Raw Materials by Risk Assessment,
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Introduction to Process Characterization: Concepts and Strategies,
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Re-filtration Validation,
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Transport Validation.
