GCP Consulting

Raland Compliance Partners provides internationally renowned clinical leadership professionals experienced in all aspects of clinical product development. Raland develops simple, common sense strategic solutions to seemingly complex situations, allowing our clients to focus on critical activities, averting regulatory risks.

Clinical & Pre-clinical Support

Raland Compliance Partners leads the way in providing clinical support through every step of the process.

  • Clinical trial management
  • Clinical quality auditing
  • Clinical monitoring
  • Clinical research training
  • Clinical supply services
  • Biostatistical consulting
  • Data management
  • Clinical pharmacology support
  • Packaging & labeling compliance
  • Vendor management
  • Vendor qualification and audits
  • Risk-based Clinical Monitoring Plan development or review
  • Project management
  • Global supply chain management
  • QP support
  • Global pharmacovigilance
  • Software validation
  • Regulatory readiness audits
  • IRB/Ethical Committee assessments
  • Service provider assessment (CRO, IVRS, EDC, etc.)
  • Submission review and assessment
  • Quality systems design and implementation
  • SOP development and training
  • Global Distributed Training — from traditional to multimedia, from monolingual to multilingual
    • Regulatory compliance (GxP)
    • Investigator meetings
    • Project training and support
  • Clinical document foreign language translation services
    • Informed Consent forms
    • Study documents
    • Reference manuals
    • Investigational product labeling
    • Investigator meeting materials

Regulatory Affairs

Raland regulatory professionals can work with you to successfully navigate the ever-changing regulatory process.

  • Preparation and review of regulatory submissions
    • IND, CTA, eCTD, CTX, IDE, CTN, NDA, ANDA, MAA, BLA, PMA, and 510(k)
  • Document control system assessment
  • eCTD vendor audits
  • Review and preparation of Drug Master File (DMF) and EDMF
  • FDA 483/Warning Letter/Consent Decree response