Insite Quality Assurance
Insite Quality Assurance, Inc. provides quality contract services to the bio-pharmaceutical, device, nutritional supplements, and veterinary medicines industries, specializing in new product development. Their global presence offers extensive expertise and efficient services to ensure quality development outcomes and shorten time to market for new medical therapies.
Industries
Nr. of Employees
small (1-50)
Insite Quality Assurance
Services
Audits of interactive voice/web response systems and related systems to ensure control of study randomization and investigational product supply.
Evaluation of written procedures and quality systems to identify gaps against regulatory or operational expectations and provide remediation recommendations.
Preparation for regulatory authority inspections through mock inspections and readiness assessments to improve performance in pre-approval and routine inspections.
Audits to assess compliance of quality systems with applicable regulations and internal policies.
Development and drafting of standard operating procedures to define operational expectations and support quality systems.
Clinical monitoring services to oversee study conduct and compliance with protocol and regulations.
Audits of interactive voice/web response systems and related systems to ensure control of study randomization and investigational product supply.
Evaluation of written procedures and quality systems to identify gaps against regulatory or operational expectations and provide remediation recommendations.
Preparation for regulatory authority inspections through mock inspections and readiness assessments to improve performance in pre-approval and routine inspections.
Audits to assess compliance of quality systems with applicable regulations and internal policies.
Development and drafting of standard operating procedures to define operational expectations and support quality systems.
Clinical monitoring services to oversee study conduct and compliance with protocol and regulations.
Expertise Areas
- Quality assurance for pharmaceuticals, medical devices, nutraceuticals, and veterinary products
- Clinical trial system validation and audits (randomization and trial supply systems)
- Regulatory inspection readiness and mock inspections
- SOP and technical/regulatory documentation development
Key Technologies
- Randomization and trial supply management systems (IVR/IWRS)
- Quality Management Systems (QMS)
- Regulatory inspection methodologies
- Clinical trial monitoring processes
News & Updates
Maintaining control of study randomization and IMP supply chain requires well-constructed and validated systems that...
Written procedures describe operational expectations. A GAP Analysis ensures that all components of that system are...
Regulatory Authority pre-approval inspections are a routine part of the development cycle. Approaching inspections with confidence is ...
Maintaining control of study randomization and IMP supply chain requires well-constructed and validated systems that...
Written procedures describe operational expectations. A GAP Analysis ensures that all components of that system are...
Regulatory Authority pre-approval inspections are a routine part of the development cycle. Approaching inspections with confidence is ...