Mergers and acquisitions enable a company to stretch its competitive advantages across multiple markets and 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 alignment experts understands the evolving regulatory environment and compliance requirements surrounding the M&A process and can help plan and manage the effort efficiently. 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 and 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 legal entity alignment phase-wise services include:
Planning
- Regulatory impact assessment
- Health authority documentation for legal entity change
- Planning for the scope of volume and nature of products
- Product pipeline review
- Analysis of development risks, milestones, and timelines
- Development plans for regional markets
- CCDS support
- Label development
- CCDS and labeling reconciliation
- Proofreading of artwork texts
Document authoring and submission
- Regulatory document preparation and submissions of variation application (including legal and administrative documents like CPP, FSC, LOA, POA, GMP, declaration letters) for several regions, including APAC, LATAM, EU, AFME, and North America
- Respond to health authority questions to ensure quick approval to reflect new marketing authorization holders
- Planning and coordination for sample submissions