Systems Validation
Record and data-keeping matters, whether a custom system or industry-leading validation, we've got you covered.
GxP Compliance
As the industry evolves, so do FDA requirements. We're fluent in Dietary Supplement CGMP, ensuring compliance.
Record Keeping
JAF Consulting ensures client production and process records are FDA complaint to avoid the need for corrective action.
JAF Consulting is an agile, smart, and proud consulting partner to life science companies with a passion for early-stage organizations and quality compliance.
Our team of industry-leading consultants and compliance experts have decades of experience between us, not only navigating the labyrinth that is pharmaceutical and nutraceutical compliance but setting the bar in our own right.
We’re committed collaborators, supporting the development and implementation of good (and compliant) manufacturing practices.
Furthermore, we protect and champion client interests in any and all findings throughout FDA and other regulatory commissions’ non-compliance inspections and audits—keeping production and market-entry timelines on track.
How We Show Up:
- Quality Management Systems
- FDA cGMP Compliance
- Risk Management Auditing
- Compliance Action Plan Development
- Record-keeping Protocols
- 21 CFR Part-11 Compliance
- Label & Packaging Guidance
- Import/Export Regulation & Compliance
- Marketing & Promotional Compliance
- Form 482 & 483 Inspection Remediation
- Education, Training, & Workshops
- General Advisory & Consulting