Summary

regulatory compliance, quality assurance, quality training, quality audit, auditing, training, medical device, product registration, import, export, international products, commercialization, clinical studies, performance testing, GLP, GCP, GMP, regulatory affairs

Description

CORE COMPETENCIES: (1) Project Management: We help companies reach a state of compliance with their documentation system and business operations. (2) Strategic Business Planning: Our in-depth knowledge of government requirements and industry standards has helped companies bring products to the marketplace in over 50 countries. (3) Team Support: We are a key resource on project teams for our analysis of compliance requirements and solutions. SERVICES: We focus on 7 service areas - (a) quality training; (b) document review; (c) procedure, policy, guidance document writing; (d) pre- and post-approval government filings; (e) auditing; (f) audit preparation; and (g)project team support. DIFFERENTIATORS: Over 20 years in the regulated industry dedicated to serving our customers with real-time solutions to meet compliance standards by implementing a lean approach to work practices. We service domestic, international, startup, midsize, and large companies.

Special details

Not applicable.

Profile

  • Incorporated in
    Texas
  • Established since
    2013
  • Main/Branch
    Branch

Address

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