About Us
Comprehensive QRC Services
Comprehensive QRC Services
Comprehensive QRC Services
We provide comprehensive quality, regulatory, and compliance solutions for Pharmaceutical, Biologics, Medical devices, Packaging materials, and Diangositcs manufacturers of all sizes
Perspective & Experience
Comprehensive QRC Services
Comprehensive QRC Services
We offer a diverse portfolio of expertise, coming from our decades of industry and agency experiences in the Quality, Regulatory, Compliance, and Risk Mitigation disciplines. We work with you to design our solutions to strategically support you with our in-depth technical expertise and project-based solutions. All we do always centers ar
We offer a diverse portfolio of expertise, coming from our decades of industry and agency experiences in the Quality, Regulatory, Compliance, and Risk Mitigation disciplines. We work with you to design our solutions to strategically support you with our in-depth technical expertise and project-based solutions. All we do always centers around ensuring and upholding product and process quality, well within the business realities of our clients.
We understand and believe in knowledge transfer and in every project we undertake we make sure to instill a sustainable quality program that survives and thrives without us being on the site. Even though we love to help our clients again and again, we believe in empowering our client teams with knowledge and tools that they can manage and survive without inviting consultants time and again. We engage leadership and teams at all levels to ensure responsibilities are well understood and proper control processes are in place to maintain quality across all phases of product life cycle. Please see our quality practices section for more details about our current portfolio of services.
Our Practices
Comprehensive QRC Services
Our Practices
Most successful businesses will tell you they could not have accomplished their goals without help. Our core principles, in-depth expertise, and strong mission shape our efforts
Our portfolio of practices includes:
Operations Support for your Quality Management System Requirements
Ø Creating a robust QMS structure
Ø SOPs writing
Ø Validati
Most successful businesses will tell you they could not have accomplished their goals without help. Our core principles, in-depth expertise, and strong mission shape our efforts
Our portfolio of practices includes:
Operations Support for your Quality Management System Requirements
Ø Creating a robust QMS structure
Ø SOPs writing
Ø Validations and Qualifications
Ø Mfg Batch Reviews
Ø Post Market Surveillance
Ø Complaint Management
Ø SOPs writing
Auditing and Assessments
Ø Internal Audits
Ø 3P Audits
Ø Supplier Audits
Ø CAPA effectiveness assessments
Laboratory Controls
Ø Computer Systems
Ø Data Integrity Assessment and Risk Assessment
Ø OOT/OOS Investigations
Ø Report writing support
Quality Systems and Training
Ø CSV system design and implementation
Ø Designing management controls
Ø Design controls and risk management
Ø Robust training based on behaviors and deficiencies
Ø HA Remediation and Response writing support