Quality Unit Services

Quality Systems: 

	GxP (GMP, GLP, GCP), GAMP, and QSR regulation consultation, strategy and gap analyses
	Development of customized Corporate Quality Systems Master Plans, including integration with any client desired elements related to universal quality enhancement principles such as CQI, ISO, TQM, six sigma
	Quality and Technology Integration planning focusing on the technology platform(s) and quality/compliance goals of the individual client
	Compliance Enhancement Programs for drugs, biologics, devices, and combination products
	CAPA System development and/or tracking execution

Quality Assurance:

	Planning and execution of Quality Assurance Review projects such as Contract Manufacturer or internal batch records (including manufacturing, testing and labeling/packaging), validation protocols/ reports and GxP development reports
	Standard Operating Procedure (SOP) and Change Control system development and implementation Master Documentation development for manufacturing and testing SOP writing
	Training program development and providing on-site or distance training courses training system and information tracking

Quality Control:

	Implementation and evaluation Quality Control (laboratory) systems Identification, set-up and/or management of Contract Laboratories (GxP)
	Development, evaluation and/or execution of Stability programs
	Validation services for methods and equipment
	Product trouble-shooting and investigation

Quality Management:

	Supplier Quality Agreement negotiation on behalf of clients
	Quality Project Management of GxP Contract Service Providers to meet client requirements
	Technical writing and/or review for communications with regulatory agencies, including INDs, NDAs, BLAs, DMFs, and annual reports

Quality/compliance:

	Internal and external Supplier Audits according to US and EU regulatory requirements and/or unique client requirements
	Remediation Programs (e.g. for required actions related to FDA Form 483, warning letters and consent decrees)
	Mock inspections including the use of team-based approaches with technical specialists to cover the area(s) of interest to the client