Raland Compliance Partners

Your Regulatory Compliance and Remediation Partners from Product Development to Patient Delivery

Compliance Sustainability

Drawing on our full suite of consulting and communications services for the pharmaceutical, biotech and medical device industries, we offer a complete, end-to-end solution for Compliance Sustainability. We bring together several relevant core competencies at Raland Compliance Partners, including:

  • Strategic consulting expertise in FDA compliance
  • Instructional design capabilities
  • Knowledge-management tools

The result is a robust, comprehensive and sustainable approach to compliance issues. We adhere to Quality by Design principles and infuse them during the C&Q process and beyond. We implement OTJ-based training programs, using information provided by subject matter experts, delivered via e-learning or live training. Our solutions ensure that immediate issues are resolved and compliance is sustained into the future.

Sustainable Compliance and Remediation

  • Compliance & Remediation
  • Regulatory Support
  • Manufacturing & Plant Solutions
  • Clinical & Pre-Clinical Support
  • Quality Systems Implementation
  • Training Solutions

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

Regulatory Support

  • Preparation & Review of Regulatory Submissions:
    • IND
    • CTA
    • eCTD
    • CTX
    • IDE
    • NDA
    • ANDA
    • MAA
    • BLA
    • PMA
    • 510K
    • CSR
  • CMC Services & Document Submission
  • eCTD Vendor Audits
  • Review & Preparation of Drug Master Files (DMFs) and EDMFs

Train for Compliance, Sustain for Operational Excellence

  • Industry leading SMEs
  • Industry experienced instructional designers
  • SOPs
  • Custom training
  • E-Learning for PC, tablet, and smartphone
  • Instructor-led, media, and training Delivery