Our Capability Model designed to cover the healthcare value chain
Deals Strategy and Execution
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Our services and experience include working with PE, VC, and multinational corporations across deals lifecycle to conduct:
a) Due Diligence Activities across regulatory, quality, commercial, operations, and compliance.
b) Pre-close planning, including all the activities required for a successful Day 1.
c) Post-close planning and execution activities depending on the type of deal. Experience includes brand changes, marketing authorization holder changes, process / QMS and system changes, labeling changes.
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Our services and experience include Global IMO / SMO support running transition management and legal entity rationalization in 100+ countries.
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Services and experience includes:
a) drafting global TSAs and Quality Agreements by function, product lines, countries, and manufacturing sites.
b) In depth understanding of the regulatory requirements in 100+ countries that may impact key TSA and Quality Agreement requirements
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Experience with conducting process and system assessments, including:
a) Facilitating process development sessions, which includes building process objectives, detailed steps, RACI, and system interactions
b) Developing and drafting end to end process maps, SOPs, and Work Instructions
c) Conducting global and affiliate level training
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Our services and experience include conducting:
a) global benchmark surveys for the organization or specific functional areas
b) current state assessment and designing future state operating / organization model based on industry benchmark and experience supporting other peer companies
c) global assessment of roles required by regulatory requirements in 100+ countries
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Our services and experience include:
a) Implementing technology enabled tools for current legal entity landscape assessments
b) For integration or separation, leading legal entity diligence and rationalization (merger, liquidation, asset transfer, etc.)
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Process Optimization and System Implementation
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Expertise include:
a) Vendor Assessments for RIM, UDI, QMS, and Ad/Promo systems
b) Business Support for System Implementation
c) UAT Development and Testing
d) IOQ/PQ Protocols and Execution
e) Data Enrichment and Migration Support
Organizational Change Management
Overall Consulting and Functional Support
Our Expertise
Research and Development
R&D Resource Planning and Management
Cross-functional Program Management Support for New Product Development
Submission Cycle Time Assessment and Optimization
Design Control and Design Transfer Support
Regulatory Affairs and Operations
Global Regulatory Strategy and Plan for New Product Introduction (NPI) and Label Expansion
Submission Preparation and Compilation Support
Submission QC Review
Regulatory Commitments and Variation Management
Health Authority Interactions Strategy and Pre-submission Meeting Support
Registration Management (Renewals / Withdrawals)
Advertising and Promotional Material Regulatory Review
Global Label and Artwork Management
Global Labeling Strategy
Retrospective Labeling Review and Remediation Support
Labeler Code Management (UDI, NDC, GS1, GTIN)
Label Expansion Support
Label Content and Artwork / Graphics Development
Labeling QC Review
Labeling Review and Implementation Support
Quality, Compliance, and Remediation
Quality Management System Stand-up (System, Process, Training)
Internal, Supplier, and Mock Audit Support
Global Inspection Readiness
Consent Decree, Warning Letter, and Audit Finding Remediation Support
Quality and Supplier Agreements
REMS Program and Risk Assessments
Annual Reports
Case Processing and Complaint Handling
Adverse Event Reporting
NCs, CAPAs, and Change Management Support
QMS Trainings
Commercial
Global Launch Strategy and Planning
Global Market Expansion Planning
Advertising and Promotional Material Review and Process Management (Commercial and Regulatory Review Support)
Operations and Supply Chain
Production Planning Support (Process and Tools)
Raw Materials and Inventory Management
Waste Reduction and Continuous Improvement
Cost reduction
Capex investment planning
Automation deployment
Equipment and Process Validation
NPI Tech Transfer and Scaling for Commercialization
3PL and Distribution Network Planning