SERVICES
Regulatory Compliance
All products must comply with local and international regulatory requirements. Complying with the Food and Drug Administration (FDA) in the United States or Health Canada requirements at the same time meeting the ISO 9001 and 17025 guidelines.
Quality System Documentation:
Assisting in the creating or updating of regulatory documents required for OTC drug manufacturing or testing approval. This includes preparing thorough databases that contain information on the product's safety, efficiency, and quality.
Labeling and Packaging Compliance:
Proper labeling and packaging of cosmetic, OTC drugs must meet regulatory requirements. This involves reviewing and informing on the content of labels, instructions for use, and packaging materials to ensure they are accurate, clear, and in compliance with regulations. Ensuring that proper microbiological, chemical and stability testing requirements are met.
Quality Assurance:
Cooperating with quality assurance teams to establish and maintain good manufacturing practices (GMP) and good laboratory practices (GLP) for cosmetics, OTC drug and nutritional dietary supplement production. This involves ensuring that the manufacturing processes meet quality standards and that the facilities are inspected and approved by regulatory authorities. Helping with cleaning and sanitizing validations, water system validations or laboratory and manufacturing equipment IQ, OQ, PQ protocols and reports.