Helping You Meet Regulators’ Expectations Throughout the Product Lifecycle
At every point in the product lifecycle — from your product’s marketing authorization application (MAA) to launch preparations — effective regulatory project management is crucial to attain positive regulatory outcomes and achieve business goals.
At ProPharma Group, our experts have extensive experience combining our scientific, regulatory, and business knowledge to help products that are developed, manufactured, or distributed meet regulators’ expectations at regional, national, and local levels.
As your regulatory project management partner, we work with you to help you understand the regulatory framework, including regional trends, and monitor the impact of changing regulations on submission strategies to ensure compliance and achieve objectives at every step of the process.
Operational and Strategic Regulatory Experts
As an extension of your team, our experienced consultants support you with operational and strategic regulatory project management throughout the product lifecycle, from both a global and regional perspective.
We provide flexible off-site support within your organization or with our network of consultants throughout the European Union (EU)/European Economic Area (EEA) to support you with:
- Regulatory submission strategy: We provide strategic input and guidance on regulatory requirements and regulatory input on procedural and documentation requirements. We also develop, execute, and maintain submission delivery plans and compile, prepare, review, and submit regulatory submission documents to authorities
- Project teamwork and stakeholder management: We manage team coordination and communication, and provide status updates to partners, team members, and designated stakeholders
- End-to-end planning, coordination, and execution of regulatory procedures and submissions: We develop and manage timelines, milestones, and techniques to keep the process on target
- Regulatory due diligence for potential and new acquisitions: We anticipate regulatory obstacles and emerging issues throughout the product lifecycle and collaborate with members of regulatory and related teams to develop effective solutions
- Regulatory risks and opportunities: We propose mitigation/regulatory solutions to cross-functional teams