Breckenridge’s Regulatory Affairs, Quality Assurance and Technical Support departments offer expertise in a wide variety of matters from 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 department has extensive experience with compilation & submissions of ANDAs to FDA:

• Advise foreign partners on US regulatory requirements
• Assist in bioequivalence strategy
• Sponsor and manage bioequivalence studies
• Liaison with FDA at all stages of ANDA prosecution, including Deficiency Responses
• Provide fully-validated eCTD submission services 
• Maintain ANDAs through Post Approval (Drug Listing, Annual & Periodic Reports, Supplements (as needed))

Our experienced Quality Assurance team handles all of the following:

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

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