A Wealth of Capabiliites to Serve a Regulated World
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Transcript of A Wealth of Capabiliites to Serve a Regulated World
1Copyright 2014
Raland Compliance Partners LLCCHICAGO, IL • FAIRPORT, NY • ROCKVILLE, MD • MINNEAPOLIS, MN • CHARLOTTE, NC
© Raland Compliance Partners 2016
“Your sustainable compliance and remediation partners”
2Copyright 2014
Raland Compliance Partners LLCCHICAGO, IL • FAIRPORT, NY • ROCKVILLE, MD • MINNEAPOLIS, MN • CHARLOTTE, NC
© Raland Compliance Partners 2016
Unique In The Compliance Industry
Raland Compliance Partners offers a full spectrum of Regulatory and Compliance services; from product inception, manufacturing, training and remediation to sustainable compliance.
Raland Technologies
1999Fairport, NY
Compliance Partners
2002Barrington, IL 2014
3Copyright 2014
Raland Compliance Partners LLCCHICAGO, IL • FAIRPORT, NY • ROCKVILLE, MD • MINNEAPOLIS, MN • CHARLOTTE, NC
© Raland Compliance Partners 2016
Competencies
…Employing a Core Team of 135+ supported by over 200 SME’s and Technical Resources
Regulatory Affairs
Quality Project Manage-
ment
Training
Computer SystemsValidation
Clinical Compliance
Auditing
FDA Experts
Compliance Auditing
Translation Services
4Copyright 2014
Raland Compliance Partners LLCCHICAGO, IL • FAIRPORT, NY • ROCKVILLE, MD • MINNEAPOLIS, MN • CHARLOTTE, NC
© Raland Compliance Partners 2016
…Your Regulatory Compliance and Remediation Partners from Product Development to Patient Delivery.
• Compliance & Remediation
• Regulatory Support
• Manufacturing & Plant Solutions
• Clinical & Pre-Clinical Support
• Quality Systems Implementation
• Training Solutions
Sustainable Compliance and Remediation
5Copyright 2014
Raland Compliance Partners LLCCHICAGO, IL • FAIRPORT, NY • ROCKVILLE, MD • MINNEAPOLIS, MN • CHARLOTTE, NC
© Raland Compliance Partners 2016
Industries We Serve
Biotech Medical Devices
Veterinary MedicineNutriceuticals
Pharmaceutical Academic Research
Food Cosmetics
6Copyright 2014
Raland Compliance Partners LLCCHICAGO, IL • FAIRPORT, NY • ROCKVILLE, MD • MINNEAPOLIS, MN • CHARLOTTE, NC
© Raland Compliance Partners 2016
Raland Compliance Partnerships
7Copyright 2014
Raland Compliance Partners LLCCHICAGO, IL • FAIRPORT, NY • ROCKVILLE, MD • MINNEAPOLIS, MN • CHARLOTTE, NC
© Raland Compliance Partners 2016
• Compliance Auditing and Mock Inspections (GMP,GLP, GCP, ISO & QSR, FDA, EMA,PMDA)
• Remedial and Strategic Solutions
• FDA 483/Warning Letter/Consent Decree Response and Remediation
• Compliance Risk Assessment and Corrective And Preventive Action (CAPA) Planning and execution
• Quality Assurance, Quality Control, and Analytical Support
Remediation & Compliance Support
8Copyright 2014
Raland Compliance Partners LLCCHICAGO, IL • FAIRPORT, NY • ROCKVILLE, MD • MINNEAPOLIS, MN • CHARLOTTE, NC
© Raland Compliance Partners 2016
• Preparation & Review of Regulatory Submissions:
• CMC Services & Document Submission• eCTD Vendor Audits• Review & Preparation of Drug Master Files
(DMFs) and EDMFs
Regulatory Support
• IND • CTX • ANDA • PMA
• CTA • IDE • MAA • 510K
• eCTD • NDA • BLA • CSR
9Copyright 2014
Raland Compliance Partners LLCCHICAGO, IL • FAIRPORT, NY • ROCKVILLE, MD • MINNEAPOLIS, MN • CHARLOTTE, NC
© Raland Compliance Partners 2016
• Validation Master Planning• Facility, Utility & Equipment
Commissioning/Qualification• Computer & Software Validation • Cleaning Validation• Process Validation • Methods Development & Validation• Plant Controls and Systems• Plant Procedures and Policies• Plant E-Solutions• Tech Transfer
Manufacturing & Plant Solutions Support
10Copyright 2014
Raland Compliance Partners LLCCHICAGO, IL • FAIRPORT, NY • ROCKVILLE, MD • MINNEAPOLIS, MN • CHARLOTTE, NC
© Raland Compliance Partners 2016
• Clinical Trial Management• Clinical Monitoring• Clinical Research Training• Clinical Supply Services• Biostatistical Consulting • Data Management• Global Pharmacovigilance• Clinical Pharmacology Support• Packaging & Labeling Compliance• Vendor Management• Risk Based Clinical Monitoring Consulting
Clinical & Pre-Clinical Support
11Copyright 2014
Raland Compliance Partners LLCCHICAGO, IL • FAIRPORT, NY • ROCKVILLE, MD • MINNEAPOLIS, MN • CHARLOTTE, NC
© Raland Compliance Partners 2016
• Clinical Investigator Sites• Phase I Units• Pharmacovigilance • Vendor Audits
CROs AROs SMOs EDC Vendors Statistical Vendors Central Laboratories Specialty Laboratories IVRS/IWRS Vendors
• Trial Master Files (e-copy & hard copy)
Clinical Quality Assurance Auditing
12Copyright 2014
Raland Compliance Partners LLCCHICAGO, IL • FAIRPORT, NY • ROCKVILLE, MD • MINNEAPOLIS, MN • CHARLOTTE, NC
© Raland Compliance Partners 2016
Product Development
Design Controls
Laboratory Controls
Purchasing ControlsManufacturing
Shipping &
Receiving
Complaint Handling
Post Market Surveillance
Quality ManagementSystem
• ICH Q7A/Q9/Q10• FDA 210/211• FDA Part 11 • FDA 820• ISO 9001• ISO 13485• ISO 14971• IEC 62304
Quality Systems Implementation
13Copyright 2014
Raland Compliance Partners LLCCHICAGO, IL • FAIRPORT, NY • ROCKVILLE, MD • MINNEAPOLIS, MN • CHARLOTTE, NC
© Raland Compliance Partners 2016
Training for Sustained Compliance• Industry Leading SMEs• Industry Experienced
Instructional Designers• SOPs• Custom Training• E-Learning for PC
and Mobile• Instructor-Led Media
and Training Delivery
14Copyright 2014
Raland Compliance Partners LLCCHICAGO, IL • FAIRPORT, NY • ROCKVILLE, MD • MINNEAPOLIS, MN • CHARLOTTE, NC
© Raland Compliance Partners 2016
Language Translation Services• Instructions for Use (IFU)
• Labeling
• Service & Repair Manuals
• Software Localization
• Translation Validation
• 34+ Language Capability
• Spoken Interpretation Services