Technical Operations

Technical Operations

Breckenridge's technical group offers wide variety of expertise in Regulatory Affairs, Quality Assurance and supporting Product Development through ANDA submission, approval and product launch.

Our Product Development team provides support services from inception to launch:

• Development support

• Collaboration with finished-dose manufacturers on a global basis
     o Quality by Design
     o Compliance assurance with FDA standards

• Launch support including process validation strategy development

Our Regulatory Affairs team has extensive experience with compilation & submissions of ANDAs to FDA, providing:

• Advice to domestic and foreign partners on US regulatory requirements

• Pharmacovigilance

• Labeling: Oversight of all FDA requirements for content and format

• Liaison with FDA at all stages of ANDA prosecution, including Deficiency Responses

• Analysis and implementation of new and changing FDA Regulatory Guidance, Regulations & Compliance

 • Fully-validated eCTD submission services

 • ANDA support through Post Approval (Drug Listing, Labeling Changes, Annual & Periodic Reports, Supplements)

Our Quality Assurance team handles all of the following:

 • Vendor (CMOs, 3PL) oversight 

 • Quality Agreements

 • SOPs – comprehensive coverage of Quality System elements

 • cGMP Compliance Audits of contract labs, API Manufacturers, and CMOs

Breckenridge also has extensive experience concerning the regulatory requirements for Dietary Supplements and Medical Foods.