Abbreviated New Drug Application (ANDA) Submissions

Abbreviated New Drug Application (ANDA) Submissions

The United States encourages the use of generic medicinal products through the Abbreviated New Drug Applications (ANDA) process as a low-cost alternative to innovator/branded drugs. However, meeting the ever-evolving ANDA submission requirements can be challenging for manufacturers. That’s why it is very necessary to address Abbreviated New Drug Application (ANDA) Submissions

Understanding ANDA Filing Process Requirements

Manufacturers must comply with specific requirements for ANDA filing, including QbD product development, QOS format for Module 2, and implementation of the GDUFA program. Regulatory experts can assist manufacturers in adhering to these requirements

Role of Regulatory Experts

Regulatory experts can speed up the US FDA review process by providing cost-effective, RTR compliant, and timely submissions and approvals. They can help manufacturers ensure their products enter the market safely and achieve ultimate commercial success by adopting a holistic risk management approach and understanding ANDA submission requirements

These companies ANDA Filing Capabilities

These companies offers extensive capabilities in ANDA application submissions, including dossier preparation and submission, product development, lifecycle management, and post-approval support. Companies guarantees timely and RTR compliant submissions, resulting in quicker approval and market entry for manufacturers

Benefits of These companies Filing Services

These companies ANDA filing services help manufacturers reduce costs, increase efficiency, and minimize risks by providing timely and compliant submissions. Our Regulatory experts have experience with various product types, including oral solids, injectables, ophthalmic, inhalation, and topical products.

These companies Holistic Approach to ANDA Filing

These companies takes a holistic approach to ANDA filing, starting from the initial product development stage and continuing through lifecycle management and post-approval support. By providing end-to-end Regulatory support, These companies helps manufacturers stay compliant, reduce risks, and achieve commercial success.

Why Manufacturers Should Choose These companies for ANDA Filing

These companies have proven to be a dependable and highly skilled regulatory partner, providing a comprehensive range of services for Abbreviated New Drug Application (ANDA) submissions. Their services encompass the entire process, from strategy development to regulatory compliance, and their risk management approach ensures that manufacturers can bring their products to market efficiently and securely. With a deep understanding of the ANDA submission requirements set forth by the US FDA, these companies offer manufacturers the expertise necessary to file their applications quickly, safely, and cost-effectively. For any manufacturers looking to file an ANDA, These companies should be a top choice due to their reliability, experience, and extensive capabilities in the field.

Expertise in Abbreviated New Drug Application (ANDA) Submissions

  • Templarpharma provides expertise in Abbreviated New Drug Application (ANDA) submissions.
  • They offer strategic support for ANDA submission roadmaps and document generation.
  • Regulatory consultation is available during product development and manufacturing phase.
  • They assist in selecting the Reference Listed Drug and reviewing specifications.
  • Templarpharma helps with compliance to IIG database and Q1/Q2 compliance for certain products.
  • They provide guidance on batch size requirements and risk mitigation plans.
  • Pre-submission FDA interactions and administrative activities are supported.
  • ANDA document checklists and regulatory assessments are provided.
  • They can help generate additional documents for Refuse to Receive (RTR) compliance.
  • SPL submissions and compilation of quality ANDA packages are offered.
  • Interaction with the US FDA for ANDA approval and resolving critical RTR issues.
  • Regulatory strategy and response preparation for queries during the approval process is also available.