Consumer Healthcare

An international consumer healthcare company acquired a complex brand portfolio and retained RegAgile to find out if the portfolio could be rolled out to new markets (>6 countries) in SEA and provide strategies to overcome potential hurdles

The regulatory documentation of the portfolio was assessed, and issues identified via conducting Due diligence of product dossiers and gap analysis (e.g., noncompliance, lack of proof of substantiation, strength of Actives ingredients, indications.) Proposed strategies to enable market access with minor changes to product dossier and developing new clinical substantiation documents.

Risk analysis was provided on the potential consequences of registering products which were noncompliant.

Cost based approach to create value proposition for the client was adopted