Establishing or revising a quality management system (QMS)Â
Drafting Standard Operating Procedures (SOP)
Preparation and review of Finished Product Specifications, Master Manufacturing Records, and Batch Records
Product label review
Supplier Qualification Program
Assessment and release of raw materials and finished products
Developing stability testing protocols for ingredients and finished products
Conducting cGMP audits
FDA and regulatory audit readiness
Responses to FDA Warning Letters and 483 observations
Employee training programs
Investigation of complaints, deviations, and non-conformances
Product label review