REGULATORY SUPPORT
Quality Program Design and Strategy
We provide thorough quality systems design and planning services to companies looking to develop or assess in-house Quality Program and Quality Unit performance, transition to/from third-party testing labs, develop and implement a combination strategy to reduce costs, and much more depending on the goals and needs of the company and the respective business model as well as product types.
• Structure Function Claims
• Review of Labels
• Review of Marketing Material (websites, social media, etc.)
• Facility and Supplier/Vendor Audits (GMP, SQF, ANSI, etc.)
• Technical Documentation Development and Training
• SOP and Master Control Documents
• Best Documentation Practices
• FTC Action, FDA Inspection Support and Response Letters
We can support you in the event of an onsite inspection by the FTC or FDA or other regulatory body assessing your state of compliance. For pre-approval inspections, we can provide audit walk-through’s to identify the critical elements of your Quality System that are potential liabilities. Upon inspection with the FDA, if you received corrective orders or 483 Observations, we can work with you and your team to prioritize and implement the necessary corrective actions, including FDA Inspection Response Letters.
Quality Control and Quality Assurance
•Protocol generation testing of novel raw materials
•Protocol review for qualification and/or testing of raw materials
•Microbiological equipment evaluation
•Microbiological equipment qualification (Generation of IQ/OQ/PQ documents)
•Review of SOP for QC Microbiology, QC Chemistry, and Quality Systems
•Data review and/or approval
•Technical document generation – trend reports, directions for use, SOP, regulatory submission sections
•QC Laboratory and QA System audits
•Conduct full Out of Specification or Non-Conformance Report (NCR) investigations and issue associated reports
•Trend OOS or NCR data
•Establishing quality metrics (turnaround time, on-time completion, error rate, etc)
•Facility Auditing and Compliance Investigations
Regulatory Action Matters
•FDA Inspection Planning and Training
•Form 483 and Warning Letter resolution
•Import Detention resolution (off the “red list”)
•FSVP Plan Writing and Program oversight