Regulatory Outsource Consulting, Inc.
Phone: (281) 367-3949
info@Regoutsource.com
Welcome to Regulatory Outsource Consulting, Inc.

Specializing in

  • Early phase development activities
  • GCP audits
  • GXP training
  • Regulatory submissions

Our Services

ROC provides general consulting services in Regulatory Affairs and Quality Assurance, with specific auditing and support services in the areas of clinical research/technical writing, manufacturing and testing, preclinical development and validation activities through in-house expertise and through strategic partnerships with other industry experts.

Regulatory Affairs and Quality Assurance
Clinical Research/Technical Writing
Manufacturing and QC Testing
Preclinical Testing
Validation Activities

Regulatory Affairs and Quality Assurance

  • Consultation on regulatory development strategies
  • Development/review of regulatory submissions, including, but not limited to: IND, CTX, NDA/BLA, CTD, Drug or Biologics Master Files (DMF/BMF), Scientific Advice, Orphan Product Designations and grants, Fast Track requests, etc.
  • Representation of clients to FDA or other regulatory agencies, including meeting preparation and facilitation
  • Technical and medical writing
  • Quality GCP, GMP and GLP audits
  • Development/evaluation of training systems and preparation and conduct of training courses for GCP, GMP, and GLP compliance and related topics
  • Literature search and review
  • Compliance advice and consultancy

Clinical Research/Technical Writing

ROC works with its clients to ensure understanding of objectives, results and deliverables. All applicable regulatory requirements including ICH guidelines are followed in audits and in preparing/reviewing clinical documents.

  • GCP audits
    • Clinical Investigator sites
    • Phase1/PK units
    • Sponsor/CRO/SMOs
    • Database audits
    • Trial Master Files
    • Vendor audits/assessments
    • Laboratory audits (CLIA/CAP or GLP as required)
    • "For Cause" investigations
    • Documentation systems
    • Clinical study reports
    • Safety reporting/pharmacovigilance activities
    • Laboratory audits (CLIA/CAP or GLP as required)
  • Clinical Trial Monitoring
  • Development of clinical forms/reporting systems
  • Serious Adverse Event reporting/review
  • Development/review of clinical protocols and study reports
  • Development/review of clinical sections of regulatory submissions
  • Clinical document development/review (forms, Investigator Brochures, study manuals)
  • Consultation on clinical supplies and drug shipment issues
  • Literature search and review
  • Manuscript preparation
  • Standard Operating Procedures (SOP) development/review

Manufacturing and QC Testing

  • GMP audits of manufacturing, testing, labeling and packaging operations
    • Qualification audits
    • Vendor audits (raw materials and services)
    • API and Finished Product manufacturing
  • Review of manufacturing batch records, QC testing records, and stability studies
  • Preparation, review and evaluation of GMP documentation, including master production records, testing records, stability protocols and reports, development reports, miscellaneous forms, and SOPs
  • Preparation of CMC sections of regulatory submissions

Preclinical Testing

  • GLP audits
    • In vivo/in vitro studies and reports
    • Preclinical testing facilities and laboratories
    • Vendor qualification audits
    • Preclinical study reports
  • Preclinical protocol development/review
  • Final report preparation/review
  • Preparation of pharmacology/toxicology/pharmakokinetics sections of regulatory submissions

Validation Activities

  • Preparation/review of validation protocols and master plans (e.g. equipment, assay, shipping and facilities validation)
  • Preparation/review of final validation reports