Amy Epperly Email & Phone Number

Columbus, OH, US

Shirley, New York, US

Shirley, New York, US

• Supervise and mentor Regulatory CMC staff in the preparation of well organized, scientifically sound CMC-related regulatory submissions that comply with applicable regulatory requirements within defined timelines.
• Lead CMC staff in using internal submission preparation tools such as electronic submission spreadsheets, checklists, and templates.
• Created templates for the CMC team to use in the preparation of original and supplemental filings to ensure FDA requirements are met and to ensure consistency for all applications.
• Review and prepare original NDA and ANDA submissions for sterile injectable products compliant with FDA and eCTD requirements.
• Review and prepare supplements (CBE, CBE-30, and PAS) to FDA, to support specification, method, and manufacturing changes for lifecycle management of approved products.
• Review technical reports, summary and narrative documents for appropriate submission content, including scientific justifications, for adherence to regulatory guidelines.

Shirley, New York, US

• Prepare and submit original ANDA submissions for sterile injectable products compliant with FDA and eCTD requirements.
• Created Document Tracking System for ANDA submissions which provides clarity on the status of all documents throughout the submission process, from authoring, reviewing, to building in eCTD. This system reduces chances.
• Prepare and submit Annual Reports and Minor Changes and Stability Reports for approved products which comply with the FDA/CVM requirements.
• Communicate and provide annual report information to third party customers.
• Prepare and submit supplements (CBE, CBE-30, and PAS) to FDA, to support specification, method, and manufacturing changes for lifecycle management of approved products.
• Assess change controls for pre-approval and post-approval products to ensure the documents and products are compliant with FDA requirements.

Ingelheim Am Rhein, Rhineland-Palatinate, DE

• Prepared and submitted annual reports for approved products which comply with the FDA requirements
• Reviewed and researched FDA guidances to support filing requirements and increase understanding of industry guidances to provide high quality submissions.
• Successfully managed filings for 31 projects, both approved and unapproved for solid-oral, non-solid, and nasal spray dosage forms.
• Managed lifecycle changes for approved products and review/approve all applicable change controls.
• Submitted supplements (CBE, CBE-30, PAS) to FDA as applicable to support manufacturing, specification, and USP updates to ensure compliance to FDA and USP requirements.
• Negotiated deliverable timelines to support filing requirements and responses.

Ingelheim Am Rhein, Rhineland-Palatinate, DE

• Responsible for creating and updating specifications and analytical procedures for starting materials and packaging components using RECORD and to route through TrackWise for approval
• Updated excipient specifications to include reduced and critical testing based on laboratory created technical reports, company work instructions, and USP and IPEC requirements as a member of the Starting Material.
• Organized and lead weekly meetings with Starting Material Laboratory scientists to review specifications and analytical procedures requests and updates
• Created specifications for new excipients to be brought into the company for developmental testing and determined proper testing requirements
• Authored and Reviewer for Annual Stability Reports
• Regulatory Affairs contact for QAS Documentation group

Ingelheim Am Rhein, Rhineland-Palatinate, DE

• Quality control laboratory: Performed starting material testing, bulk release testing, stability testing, and complaint testing on pharmaceutical samples including inhalation products, solid dosage forms, and nasal.
• Performed glassware washer qualification testing to support audit preparedness
• Led team meetings and responsible for communicating sample status
• Member of the “Right the First Time” group, which aims to reduce laboratory analyst errors by implementing attention activators and providing a yearly training to the labs

Ingelheim Am Rhein, Rhineland-Palatinate, DE

• Contract Chemist at Boehringer Ingelheim Roxane Inc. in the Quality Control Laboratory
• Quality control laboratory for production support and lifecycle
• Responsible for daily balance verifications
• Perform cleaning verification testing on equipment in production of pharmaceutical products
• USP/BI test method pharmacopeia gap analysis
• Perform stability testing on pharmaceutical samples