“Your sustainable compliance and remediation partners” Competencies RCP’s core staff of 135 project managers, regulatory experts, training support staff, and translators is augmented according to your unique project requirements by an additional team of 150 consultants, all of whom share our core values and commitment to quality[‘ RCP’s core staff of 135 project managers, regulatory experts, training support staff, and translators is augmented according to your unique project requirements by an additional team of 150 consultants, all of whom share our core values and commitment to quality …Your Regulatory Compliance and Remediation Partners from Product Development to Patient Delivery.

Sustainable Compliance and Remediation Compliance & Remediation Regulatory Support Manufacturing & Plant Solutions Clinical & Pre-Clinical Support Quality Systems Implementation Training Solutions/Language Services Remediation & Compliance Support 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 2

Clinical & Pre-Clinical Support Clinical Quality Assurance Auditing 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 Quality Assurance Auditing 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)

Post Market Surveillance Quality Systems Implementation Product Development Design Controls Laboratory Controls Purchasing Controls Manufacturing Shipping & Receiving Complaint Handling Post Market Surveillance Quality Management System ICH Q7A/Q9/Q10 FDA 210/211 FDA Part 11 FDA 820 ISO 9001 ISO 13485 ISO 14971 IEC 62304

And Translation Services Training And Translation Services Industry Leading SMEs Industry Experienced Instructional Designers SOPs Custom Training E-Learning for PC and Mobile Instructor-Led Media and Training Delivery Instructions for Use (IFU) Labeling Service & Repair Manuals Software Localization Translation Validation 34+ Language Capability Spoken Interpretation Services …for Sustained Compliance, worldwide.