Projects

Outsourced Quality Support (QA/QC for Virtual Companies)
- Early in a product’s lifecycle, the company leadership needs to set the strategy for product filings, regulatory pathway, manufacturing setup, and quality management systems creation. As the company matures, these functions often transition to a maintenance mode. We will provide the QA/QC consulting based on your strategic needs in a phase-appropriate mode. Our interim management brings needed expertise while saving costs. Ms. Lan Feng has been in leadership positions setting up QA/QC/Validation functions of early stage biotech firms three times, she understands that doing the right thing right way in first time is critical for company’s success.

QC support, data review, OOS investigation, etc.
CMO / CTL Selection Support
- Selection of the right CMO is critical. Quality review and audit should be included in the decision process. Failure to do so can cost companies multi millions dollars and delay project 1-2 years. We can provide In-person and/or virtual quality review and audits, and make sure that CMO would meet your needs both today and in the future.
Supplier Oversight / Audit
- Perform risk assessments and/or audits of critical raw material suppliers, CMO and analytical service providers to ensure their quality standards are aligned with your needs.
New GMP Facility Commissioning, Qualification, and Validation
- Stainless steel bioreactor and disposable bioreactors
- Automation of upstream and downstream manufacturing process
Internal & External Audits
- Failure to properly prepare, execute and maintain a suitable audit program is a common source of failure.
- In-person and/ or virtual options. Please contact us for details.