Over-the-Counter Drug Products
Registration
- FDA Facility Registrations
- FDA SPL Listings
- NDC Reservation
- OTC Drug Facility Registration Fees
- Labeling Requirements
Files
Design and Development Files
Label Reviews for Compliance.
Quality System Documents
Standard Operating Procedures: Creating and Reviews
Forms: Creating and Reviews
Equipment Qualifications - IQ/OQ/PQ
Equipment Validations
Process Validations
Medical Devices
Registration
- FDA Facility Registrations
- FDA Device Listings
- GUDID
- UDI
- 510K Submissions
Files
Design History Files
Design Medical Records
Technical Files
Label Reviews for Compliance.
Quality System Documents
Standard Operating Procedures: Creating and Reviews
Forms: Creating and Reviews
Equipment Qualifications - IQ/OQ/PQ
Equipment Validations
Process Validations
Cosmetics
Registration
- MOCRA Registration: Facility Registration
- MOCRA Registration: Product Listings.
Files
Cosmetic Product Files
Label Reviews for Compliance
Quality System Documents
Standard Operating Procedures: Creating and Reviews
Forms: Creating and Reviews
Equipment Qualifications - IQ/OQ/PQ
Equipment Validations
Process Validations
Dietary Supplements
Registration
Facility Registration
Product Listings
Files
Label Reviews for Compliance.
Dietary Supplement Design Files.
Quality System Documents
Standard Operating Procedures: Creating and Reviews
Forms: Creating and Reviews
Equipment Qualifications - IQ/OQ/PQ
Equipment Validations
Process Validations