A Wealth of Capabiliites to Serve a Regulated World

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Raland Compliance Partners LLCCHICAGO, IL • FAIRPORT, NY • ROCKVILLE, MD • MINNEAPOLIS, MN • CHARLOTTE, NC

© Raland Compliance Partners 2016

“Your sustainable compliance and remediation partners”

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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

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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

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…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

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Industries We Serve

Biotech Medical Devices

Veterinary MedicineNutriceuticals

Pharmaceutical Academic Research

Food Cosmetics

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Raland Compliance Partnerships

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• 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

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• 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

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• 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

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• 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

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• 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

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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

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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

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Language Translation Services• Instructions for Use (IFU)

• Labeling

• Service & Repair Manuals

• Software Localization

• Translation Validation

• 34+ Language Capability

• Spoken Interpretation Services

A Wealth of Capabiliites to Serve a Regulated World

Health & Medicine

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