Our Capability Model designed to cover the healthcare value chain

Deals Strategy and Execution

Deals Strategy and Execution

  • 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.

  • Our services and experience include Global IMO / SMO support running transition management and legal entity rationalization in 100+ countries.

  • 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

  • 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

  • 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

  • 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.)

Process Optimization and System Implementation

Process Optimization and System Implementation

  • 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

Organizational Change Management

Management Consulting and Functional Support

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