End To End
Supplement Creation
Supplement Creation
What We
Can
Do
We have formed a team of highly qualified professionals specializing in manufacturing and laboratory quality management systems, business development, process optimization, FDA GMP manufacturing quality standards, training, and leadership guidance. Our team of science-based experts will collaborate closely with you to develop customized strategies and solutions that address your specific needs.
Manufacturing Connections
Product compliance with Quality Control and Quality Assurance
- FDA Compliance-CFR 21 part 111 with Good Manufacturing Practices (GMP).
- Establish Product Specifications
- Documentation requirements (Master Manufacturing Records, Standard Operating Procedures (SOP’s), Raw Material testing, Research of adulterants to test for, Allergen statements/testing, Vendor Qualification, Quality Agreements, and more)
- Testing requirements and ISO 17025 labs
- Certificates of Analysis (CofA) guidance and review
- Out-of-Spec, Corrective Action (CAPA) plans with Root Cause Analysis
- Risk Assessments
Formulations Compliance
Marketing and Sales Consulting
- Go-To-Market strategy
- Product launch campaign
- Train your team in how quality leads to sales
- Website design | Refresh
The FDA holds the label owner responsible
for product compliance, not just the manufacturer.
The best decision you can make is giving your customer a quality product that leads to loyalty. Our team of quality assurance and quality control professionals will navigate you through the regulations and quality requirements to offer a 5-star product because quality leads to loyal customers.
