The novel combination of our leading regulatory and laboratory experts possesses the in-depth knowledge, and practical and technical application to aid in the execution of recent ANDA acquisitions, CMO migration, API sourcing and/or primary packaging configuration.

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• Recent ANDA Acquisition: After a detailed review of the existing ANDA as well as all correspondence with the FDA including deficiency notices and Complete Response Letters (CRL) we will draft a gap analysis report to identify key factors potentially lacking for a complete diagram map to commercialization.

• CMO Migration: We specialize in managing the migration of CMOs for ANDA products. By leveraging an extensive network of trusted, proven industry leaders we identify suitable, ideal partnerships to align with the specific needs of each project such as capacity constraints and unit cost reduction.

• API Sourcing: As the principal cost of material manufacturing, it is key to negotiate the best deal possible to ensure the long-term success of the commercialized product and minimise the impact of supply chain disruptions to ensure distribution quotas continue to be in range.

• Primary Packaging Configuration: As the supply chain environment continues to evolve, the need to respond to changes in the market becomes more impactful than ever. Including improvements to existing designs, we navigate the complex sea of suppliers and associated qualifications.