The Quality And Regulatory Expertise To Expedite Your Tech Transfer
For over 30 years Adare has been a trusted supplier to the world’s leading Pharma companies. Having launched numerous patient-centric products internationally, we have the regulatory, quality, and project management expertise, as well as the capacity to ensure a smooth, quick and efficient technical transfer of your project.
Our dedicated Tech Transfer team helps facilitate speed to market and minimize risk. We collaborate with you to ensure successful process transfers, anticipating equipment capabilities and ensuring Quality by Design principles
- Initiation and Transfer
- Program initiation
- Cleaning validation
- Methods transfer or development
- Process transfer
- Raw materials procurement
- Development
- Small scale CTM to support BE studies
- Scale-up to Commercial batch size
- Registration lots
- Scale-up
- Filing and Commercialization
- Launch Planning
- Validation lots
- Scale manufacturing
- Regulatory filing support
Speak With An Expert
Audrey Butler
Senior Vice President, North America Operations
Audrey Butler brings over 25 years of Quality experience to her position as Senior Vice President, Global Operational Excellence. During her career, she’s held positions of increasing responsibility in pharmaceutical manufacturing, including leadership of Analytical Development (R&D), Quality Assurance, Operations, Quality Control, and Project Management.
Audrey has served in the Quality divisions of pharma companies such as Hikma Pharmaceuticals, West-Ward Pharmaceuticals, Boehringer Ingelheim, and Ben Venue Laboratories, Inc
She has a BS in Chemistry from University of Mary Washington and a Masters in Chemistry from University of Maryland.