HOW WE CAN HELP

Product Registration and Approval: We assist with the registration of property (products) with the FDA, managing the submission process for new drugs, devices, and food products. Our team ensures that all necessary documentation and testing are completed to achieve approval.

Labeling and Packaging Compliance: Accurate labeling and packaging are crucial for FDA compliance. We review your property (product) labels and packaging to ensure they meet FDA requirements, including ingredient disclosures, warnings, and usage instructions.

Quality System Implementation: We help implement FDA-required quality systems, such as Good Manufacturing Practices (GMP), to ensure consistent property (product) quality and safety. Our services include system design, documentation, and staff training.

Audit and Inspection Preparation: Our team prepares you for FDA audits and inspections by ensuring that all aspects of your operations comply with regulatory standards. We conduct pre-audit assessments and provide guidance on addressing potential issues.

Ongoing Regulatory Support: We keep you informed about changes in FDA regulations and provide ongoing support to ensure continuous compliance. This includes updates on regulatory shifts, compliance strategies, and risk management.