Overview

Following the acquisition of a competitor’s consumer healthcare portfolio, a major consumer healthcare company faced significant regulatory challenges due to missing or poor-quality documentation.

Without proper regulatory due diligence during the acquisition, the company encountered compliance risks that threatened both existing revenue streams and future expansion into new markets.

G&L Healthcare Advisors was brought on board to provide regulatory solutions to ensure compliance, mitigate risks, and support new market rollouts.

Challenges

Compliance risk: The absence of proper regulatory documentation posed a major compliance risk across multiple markets.
Documentation gaps: Poor quality or missing Chemistry, Manufacturing, and Controls (CMC) data threatened the company’s ability to maintain current products on the market and expand into new territories.
Market roll-out delays: Without a structured approach to remediate these gaps, new market entries could face significant delays, affecting revenue and growth potential.

G&L’s Approach and Solution

G&L implemented a strategic, multi-step approach to support the client in managing the acquired portfolio and ensuring regulatory compliance:
Centralized project team setup: G&L assembled a dedicated project team in a near-shore location to provide focused, cost-effective support. The team worked closely with the client to ensure that all regulatory documentation and compliance issues were addressed efficiently.
Change of Ownership submissions: G&L submitted Change of Ownership variations across all markets, ensuring that the acquired portfolio was legally and properly transferred under the client’s ownership. This process involved liaising with regulatory authorities in multiple jurisdictions to ensure approvals were secured swiftly.
CMC gap analysis: A thorough CMC gap analysis was performed on all incoming dossiers. This step was crucial in identifying missing or incomplete documentation that posed compliance risks. By identifying these gaps early, G&L was able to develop a remediation plan to ensure regulatory compliance.
Core dossier creation for new markets: G&L constructed core dossiers using available regulatory and site documentation. These dossiers served as a foundation for expanding the acquired portfolio into new and emerging markets, allowing for a streamlined submission process. By leveraging existing data, the client was able to accelerate market entry and capitalize on new revenue opportunities.

Impact and Outcomes

Through G&L's tailored regulatory solutions, the client successfully navigated the complex challenges associated with the acquisition, ensuring both compliance and growth. Key outcomes included:
Compliance across all markets: Change of Ownership applications were approved in all relevant markets, ensuring that the client could legally market the acquired products and avoid potential compliance penalties.
Risk mitigation and remediation: G&L’s CMC gap analysis identified all potential compliance risks, and a comprehensive remediation strategy was developed and executed. This helped the client avoid costly disruptions in existing markets.
New revenue streams and market expansion: By creating core dossiers, G&L enabled the client to expand the portfolio into new and emerging markets, opening up new revenue streams and accelerating the commercialization process.