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Aerial View of Waves



GCP Training for ICH and FDA

HIPAA Training

Protocol, ICF, IFU and other study specific procedures

Trial Master File Development and Management

Informed Consent Process


Ensures that the manufacturing, packaging, labeling, and storage of investigational medicinal products (IMPs) are conducted in accordance with established quality standards

Documentation - Maintain comprehensive and accurate documentation for all manufacturing activities, including batch records, standard operating procedures (SOPs), and protocols

Quality Control - Implement robust quality control systems to ensure the quality, identity, purity, and strength of the investigational product

Facility and Equipment - Establish appropriate facilities and equipment for manufacturing, packaging, and labeling activities, ensuring they are suitable, maintained, and validated

Personnel - Employ qualified and trained personnel who possess the necessary knowledge and skills to perform manufacturing tasks effectively and in compliance with GMP requirements.

Raw Materials - Ensure that all raw materials used in the manufacturing process meet specified quality standards and are properly tested, released, and stored

Manufacturing Process - Develop and follow validated manufacturing processes that consistently produce investigational products meeting predetermined quality attributes


Packaging and Labeling - Use appropriate packaging and labeling materials that maintain the integrity of the product and comply with regulatory requirements


Quality Assurance - Establish an independent quality assurance function to monitor compliance with GMP and to conduct audits and inspections


Storage and Distribution - Maintain appropriate storage conditions to preserve the stability and integrity of investigational products during distribution and use

Record Keeping - Maintain comprehensive records of manufacturing, packaging, labeling, testing, and distribution activities, including traceability and accountability

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