c é l e r e
Innovative Solutions for Life Sciences
Understand The Challenge.
About Us
Empowering Change.
Célere provides of team of experienced engineers and industry professionals dedicated to serving the Life Sciences and Pharmaceutical community.
We understand your business and your competitive advantages, and partner with you to align your investments in design, engineering, and technologies with your business objectives...
we tackle the tough challenges.
We have the capability to service clients across the U.S. and Europe both on-site and remote, using technology, work processes and progress tracking systems to manage client deliverables.
We strive to provide clients with exceptional performance to achieve a competitive advantage while satisfying quality and regulatory requirements. We value and exercise competence, industry knowledge, and integrity in delivering results for industry-leading Life Sciences organizations.
Our Services
We are focused on delivering exceptional performance. Our Professionals partner with Life Sciences and Healthcare Institutions to improve their operational performance and regulatory compliance.
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Strategy Development
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Scope Development
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Planning/Scheduling
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Cost Analysis
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Master Validation Planning
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Procurement Coordination
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Commissioning and Startup
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Change Management
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Software Lifecycle Management
Strategy & Project Management
Strategy & Project Management
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Facilities and Utilities Qualification
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Mechanical/HVAC Equipment
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Building Management Systems
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Manufacturing Automation Systems
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Equipment Qualification
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Freezers. Autoclaves, Washers
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Factory/Site Acceptance Testing
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cGMP Validation
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Process Validation
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Cleaning Validation
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cGMP Facility &
Process Validation
cGMP Facility & Process
Validation
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Software Validation:
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cGxP Assessment (21 CFR Part 11)
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Validation Plan
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Risk Assessment
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Protocol Development
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Test Development & Execution
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Types of Systems:
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Bioinformatics Pipeline Software
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DNA Sequencing Systems (MiSeq)
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ERP/Inventory Control Systems
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Manufacturing Systems (cGMP)
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LIMS/Chromatography (cGLP)
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Clinical Systems (cGCP)
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cGxP Computer
Systems Validation
cGxP Computer Systems
Validation
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Quality Policy/Procedures/Templates
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Design Controls
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QA Project Oversight/Guidance
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Data Integrity
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cGxP Document Review and Approval
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CAPA/Quality Management Systems
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Risk Management
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cGxP Training
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Post-Market Surveillance
Quality & Compliance
Services
Quality & Compliance
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Clinical Study Design and Startup
- Site and Investigator Recruitment
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Patient Screening/Recruitment
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Electronic Case Report Form Design
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Clinical Study Management
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Clinical Data Management
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Adverse Events Reporting Solutions
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Electronic Trial Master File (eTMF)
Clinical Trials & Data Management
Clinical Trials & Data Management
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Regulatory Strategy
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Audit Preparation
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PMA Submission
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510(K) Submission
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Assessments/Audits
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Vendor Audits
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Internal Inspections/Audits
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Product Labels
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Product Recalls
Regulatory Affairs
& Audits
Regulatory Affairs & Audits
We Believe in Life Sciences.
We Know cGxP.
We Value Exceptional Performance.
Contact Information
