BioFlourish Consulting LLC
Your Partner in Drug Development through Commercial Manufacturing
Our Services
Commissioning, Qualification & Validation
Develop Validation strategies and Master Plans
Apply lean qualification approach to protocol development, based on risk assessments
Prepare SOPs and guidance documents for Validation program
GMP Quality Engineering
Quality oversight of CQV activities
Develop appropriate Quality Risk Management tools
Guidance on Change control, CAPA, Discrepancy evaluations
Manage core and sub project teams as required
Develop program strategies backed by timelines with project team and create and/or present Board materials
Ensure alignment on program strategies and core messaging
Lead team through initial IND filing
Prepare team for subsequent clinical phases and interactions with health authorities alongside Regulatory
Partner/vendor alliance management activities
Program & Alliance Management
Vendor Identification & Management
Identify vendors suitable for your organization by managing the RFP process end to end
Provide input into SOW, MSA and other key agreements
Ensure thorough technical transfer
Key liaison between vendors and company ensuring SOW is executed accordingly and invoicing in aligned with deliverables
Establish performance metrics when required
Our
Experiences
We have the great fortune of living near South San Francisco, the birthplace of biotechnology. This proximity allowed us to learn from the best including Genentech, BioMarin, Sangamo Therapeutics, Actelion and Novartis. We’ve led dozens of successful programs and have lessons learned from others. We keep these experiences in the forefront of strategy development for our customers.
Significant Products We’ve Overseen and/or Launched
In the Community
We believe in giving our time and knowledge to the community. We are involved in various non- profit Boards and often volunteer with local businesses.
Partner with us
At BioFlourish Consulting, we excel in managing programs of all sizes. With a wealth of experience, we are dedicated to helping teams crystallize their drug development strategies and streamline their approach to commercial manufacturing.
Our expertise ensures that your project receives the utmost attention and precision, from initial concept to market launch. Whether you're a small startup or a large corporation, we're here to support your journey to success.
Contact Us: We're eager to discuss your unique needs and how we can assist in achieving your goals. Reach out to us today to explore how BioFlourish can partner with you for unparalleled results.