Breckenridge Pharmaceutical, Inc.
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Regulatory / Technical Operations

Breckenridge’s Technical Operations department offers a wide variety of expertise encompassing Regulatory Affairs, Quality Assurance, Technical Services and Clinical Affairs, supporting Product Development through ANDA submission, approval and product launch. 

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

• Qualification of API suppliers
• Development support
• Collaboration with finished-dose manufacturers on a global basis
     o Quality by Design
     o Compliance assurance with FDA standards
• Launch support

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
• 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/Technical Services team handles all of the following:

• Pharmacovigilance – in collaboration with Regulatory Affairs
• SOPs  - comprehensive coverage of Quality System elements
• cGMP Compliance Audits of contract labs, CROs, and Manufacturers
• Labeling:Oversight of all FDA requirements for content and format

Our Clinical Affairs team provides expertise in:

• Selection, Qualification and Monitoring of CROs for cGCP compliance

• Development of bioequivalence strategies
• Sponsorship /management of bioequivalence studies

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


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