Compliance Sustainability

Raland Compliance Partners has over a decade of experience and a proven track record of success in clinical research compliance within the pharmaceutical, biotech and medical device industries. Our worldwide network of highly skilled personnel understands your need for complete, integrated, accurate and timely solutions.

We provide compliance solutions that encompass your business needs and goals from product development to patient delivery.

RCP Audits in United States

RCP Audits around the Globe

Global Clinical Quality Assurance Auditing

  • Quality audits and assessments:
    • Clinical Investigator Sites
    • Phase I Units
    • Trial Master Files (electronic and hard copy)
    • Databases
    • Software Validation
    • Clinical Study Reports
  • Research vendor quality assessments and audits:
    • Contract Research Organizations
    • Data Management Vendors
    • EDC Vendors
    • Other Software Developers
    • Clinical, Bioanalytical and Specialty Laboratories
    • Statistical Vendors
    • IVRS/IWRS Vendors
    • Image Management Vendors
    • Learning Management System Vendors
    • Pharmacovigilance Vendors
    • Academic Research Organizations

Inspections/Mock Inspections

Raland Compliance Partners offers the knowledge and expertise of former FDA and other regulators to help our clients prepare for expected and unexpected Regulatory Authority inspections.

  • Pre-approval Inspection Preparedness (PAI PREP)
  • Third Party Audits/Assessments/GAP Analysis (GMP/GLP/GCP/QSR/ISO)
  • Mock FDA/MHRA/EMEA/PMDA Inspections
  • Due Diligence Audits & Assessments

Compliance Solutions

The experts at Raland Compliance Partners understand the importance and urgency of industry requirements and can assist in every step of the process for you.

Our associates have decades of experience designing, training, implementing, and auditing compliance programs in the areas of Quality Systems, Risk Management, and can perform Gap Assessments for compliance with pharmaceutical, biotechnology and medical device industry regulations (FDA, MHRA, EMA, KFDA, PMDA). We work to integrate, streamline, and optimize your compliance.

Areas of Expertise

  • FDA 483 and Warning Letter Remediation and Corrective and Preventative Action (CAPA)
  • Assessments and or audits of BLAs, NDAs and ANDAs
  • Training and Education in GxP (GMP, GLP, GCP)
  • Risk Based Clinical Monitoring Assessment and Simplification
  • Assess or develop SOPs for Quality Systems including Good Document Practices (GDP)
  • Quality Assurance Systems Gap Analysis
  • Software Validation
  • Laboratory Method Development and Validation
  • Laboratory Equipment Validation

Quality Systems Assessment

  • Compliance risk assessment and corrective action plan evaluation
  • Quality assurance support
  • Quality control and analytical support
  • Analytical method development and validation
  • Development and implementation of corrective action plans (CAPA)
  • Remedial and strategic solutions