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ANDA documents

POST APPROVAL CHANGE MANAGEMENT

Our goal at The J. Molner Company is to increase the availability of generic drugs on the market to reduce the overall patient cost and eliminate drug shortages. By navigating post-approval changes to existing Abbreviated New Drug Applications (ANDAs) that are under-realized of their maximum market potential or are inactive due to a variety of challenges we offer a Turn-Key solution to our partners to rapidly reduce the time and costs to product launch.

WHY CHOOSE THE J. MOLNER COMPANY

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.

  • 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.

People disucssing business
People disucssing business

UNDERSTANDING THE DIFFERENCES

Understanding the nuances between different FDA reporting categories, our team of dedicated, passionate leaders ensures the appropriate pathway is identified to maximize efficiency of approval compliance while minimizing costs and time towards a desired outcome.

CLIENT BENEFITS

Benefits our clients can expect to receive as deliverable outcomes at project completion:

  • Regulatory Excellence

  • Impeccable Laboratory Data

  • Cost Reduction

  • Capacity Expansion

  • Supply Chain Risk Reduction

  • Accelerated Time-to-Market

  • Market Access and Impact

  • Supplier Qualifications

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BOOK A 30 MIN CONSULTATION

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