Legal Entity Change

FMD K&L understands the regulatory impact on products following an M&A and can help maintain compliance throughout the transition

Mergers and acquisitions (M&As) enable a company to stretch its competitive advantages across multiple markets and help build comprehensive service portfolios through complimentary functional integrations.

We help you achieve your integration goals with our expertise in managing large-scale pharmaceutical entity integrations. Our team of legal entity change (LEC) experts understands the evolving regulatory environment and compliance requirements surrounding the M&A process and can guide you to efficiently plan and manage the effort. We support your legal entity consolidation goals by helping to strategically integrate the marketing interests of holding authorities with required regulatory compliance.

Through our centralized Regulatory Project Management Office, we:

  • Coordinate global product launch
  • Schedule import-export timelines
  • Manage risks around border hold policies
  • Prioritize products across global markets
  • Plan & execute global regulatory submissions

We build an efficient collaboration framework integrating cross-functional activities throughout the transition period, thereby minimizing interruptions to business activities.

Our LEA (original legal entity) phase-wise services include:


  • Regulatory impact assessment
  • Health authority documentation for legal entity change
  • Planning for scope of volume & nature of products
  • Product pipeline review
  • Analysis of development risks, milestones & timelines
  • Development plans for regional markets


  • CCDS support
  • Label development
  • CCDS & labeling reconciliation
  • Proofreading of artwork texts

Document authoring and submission

  • Regulatory document preparation & submissions (CPP, LOA, POA, GMP, declaration letters) for several regions including APAC, LATAM, EU, AFME & North America
  • Planning & coordination for sample submissions

Supply chain

  • Inventory & demand planning
  • Distribution planning

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