When you contract with G & W Laboratories, Inc. to manufacture for you, rest assured we will take care of all the details. These include:

• Develop product formulations, processes, protocols and analytical research methods.

• Ensure all cGMP's are adhered to while conducting cleaning validations, documentation, pilot scale and optimization batches, process validations & stability monitoring.

• Ensure all incoming raw materials for production of products are quarantined, sampled and released only upon completion of thorough inspection and all required testing.

• Ensure accurate, timely and complete production documentation. Control and maintain all documentation pertaining to regulatory compliance.

• Direct development of and manage compliance with SOPs defining procedures on how a particular activity in any production, quality, facility, laboratory or inventory unit is to be performed.

• Ensure each G & W employee engaged in the manufacture, processing, packing, testing, or holding of a drug product shall have education, training, and experience to perform functions in compliance with cGMPs.

• Ensure compliance with all commitments made in NDAs, ANDAs, and other regulatory requirements.

• Ensure all products released for shipment by G & W have met rigorous internal standards and comply with FDA's guidances on cGMP and best practices within the industry.