As U.S. Regulatory Agents, Scandinavian Formulas, Inc. will:

• Support and assist our clients with sound regulatory advice required to meet all FDA regulations in planning and executing the manufacturing of quality active ingredients (API’s) to include in-process controls and validation, laboratory controls, record keeping and documentation.
• Prepare and submit Drug Master File (DMF) application/s to FDA.
• Address deficiency matters and submit responses to FDA.
• Review and submit annual DMF updates to FDA.
• Assist with preliminary cGMP plant audits prior to FDA inspections.
• Conduct annual plant audits.
• Coordinate DMF reference authorization between our clients and their customers.
• Review the status of US patents as related to our clients’ development.
• Update our clients with current FDA regulations and cGMP guidelines.
• Arrange for seminars and exhibitions relevant to production and compliance of bulk Active Pharmaceutical Ingredients.