Regulatory Submissions

Jeff Yuen & Associates offers a full range of regulatory submissions audits for companies desiring to have a pre-submission review, or with negative FDA findings, an audit to assess the validity of data and information. The audit includes review of a pre-submission application or an original application, with all amendments, supplements and annual reports. The application audit encompasses a complete review of:

  • Current Master Batch Records
  • Master Formulation Records
  • Manufacturing Instructions
  • Packaging Instructions
  • Component Specifications (API, Excipient, Container and Closure System)
  • Bulk & Finished Product Specifications
  • Commercial Stability Protocol
  • Manufacturing Change Authorization Summaries
  • Equipment
  • Facilities
  • Suppliers

This submission audit allows confirmation that a finished product is manufactured in accordance with parameters submitted in the application and/or subsequent correspondence, such as, amendments, supplements and annual reports.

Our in-depth knowledge and experience with regulatory requirements will assist with the pre-submission review of an application, thus ensuring the highest quality documentation to gain product registration, as expeditiously as possible. This expertise can assist in the identification of deficient areas within the original application and/or subsequent correspondence. Our highly skilled professionals can then assist in addressing the preparation of documentation to meet FDA approval requirements.

A submission audit is beneficial throughout the life cycle of an application, from the pre-submission stage to the current application stage to determine if any discrepancies between conditions identified in the application and manufacturing conditions during actual production exist. If you or your organization could benefit from a submission audit, please contact us so we can discuss your audit in depth.

The Audit Plan

Audit plans describes procedures to be used to identify any discrepancies between manufacturing conditions identified in application(s) and manufacturing conditions during actual production.
In the event an audit plan is required for agency review prior to implementation, the client and Jeff Yuen & Associates will develop the audit plan.
The audit plan includes a detailed description of the strategies and procedures to be used to conduct the audit. The plan is comprehensive, thorough, and complete, including an identification of all records, application(s), and other documentation that will be examined and all personnel (past and present) that may be interviewed.

Regulatory Affairs Services

Jeff Yuen & Associates, Inc. offers customized services to meet the client’s regulatory affairs needs for drug products and active pharmaceutical ingredients intended for the U.S. market. To address the regulatory affairs challenges of our clients, our portfolio of services:

  • Regulatory Strategy
  • FDA Communication
  • Filing Expertise
  • Regulatory Operations & Publishing
  • Labeling
  • CMC
  • Post-marketing
  • Non-Clinical/Clinical

Useful Resources