Protecting Value, Ensuring Continuity
Regulatory approval marks the beginning, not the end, of a product's journey. Post-approval changes, manufacturing updates, and regulatory maintenance activities continue throughout commercial life. Each change carries regulatory implications that must be overseen effectively.
RegOps provides lifecycle management expertise that protects your regulatory assets and maximizes product value. We help you plan changes efficiently, select optimal regulatory pathways, maintain submission dossiers, and respond to evolving regulatory requirements. Our lifecycle approach considers both immediate needs and long-term strategic objectives for each product.
Our Capabilities
From routine maintenance to complex variations.
Strategic planning for post-approval changes. We assess change impact, determine regulatory pathways, and execute submissions efficiently.
Classification and pathway assessment for changes under global frameworks. We advise on optimal filing strategies (CBE-30 vs PAS, Type IA/IB/II).
Regulatory strategy for new strengths, dosage forms, and indications. We help you expand your product's market potential within existing frameworks.
Ongoing maintenance of marketing authorizations including annual reports and renewals. We ensure your licenses remain active and current.
Systematic updating of dossiers to reflect approved changes, maintain consistency across markets, and ensure readiness for future filings.
Management of post-approval commitments and agency agreements. We track deadlines and coordinate fulfillment to ensure timely compliance.
The RegOps Advantage
We help you make lifecycle decisions that support both immediate needs and long-term strategy.
Strategic Perspective
We consider the lifecycle implications of every change, ensuring today's solution doesn't become tomorrow's problem.
Efficiency Focus
We identify the least burdensome regulatory pathways for changes, reducing submission effort and timelines where possible.
Portfolio Approach
For multi-product portfolios, we coordinate lifecycle activities to optimize resources and maintain consistent regulatory practices.
Global Coordination
We manage changes across markets, ensuring consistency of approach and minimizing regulatory risk from regional variations.