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Regulatory Consulting

Synogen's consulting regulatory Associates can assist our partner companies in the development of comprehensive regulatory plans. This helps assure that the company can bring its products or technologies to market as quickly as possible, minimizing unexpected issues related to FDA approval and compliance. They have direct contacts and relationships with the FDA, and can tap those resources to understand in advance what the FDA will need to approve certain devices, drugs, biologics or systems. They can assist with Good Manufacturing Practices (GMP/cGMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP) and Good Tissue Practices (GTP) as part of operation as an FDA-regulated business. In general, they can give guidance in validation and regulatory compliance in the pharmaceutical, medical device and biotechnology industries.

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