We are your Solutions Partner
Regulatory Information Management or RIM is technology used to increase speed, collaboration, efficiency and visibility across your entire global portfolio, improving performance at a lower cost.
Through Business Process Services (BPS), we enable customers to operate a lean, agile business without sacrificing opportunity. By combining our expertise, technology, and industry knowledge, and allow you to focus on what you do best-designing, commercializing, or sourcing medical and health-tech devices-while we anticipate and respond quickly to your regulatory needs.
Leverage the expertise of external partners to grow businesses and bring industry-changing solutions to the market.
Configure lean and agile internal operations so you can focus on customers and core competencies while partnering with a world-class regulatory, quality, and clinical business process services provider.
We help you establish scalable core RA/QA capability by leveraging an outside business process service that will design, implement, and run essential RA/QA processes vital to your business' wellbeing.
Incubators & Accelerators
A shared service designed for incubators and the start-ups they serve provides a more effective way for early-stage companies to gain access to world-class RA/QA capabilities.
Health & Wellness Retail
Managing compliance, quality, and safety risks requires specialized knowledge. Consider establishing dedicated organizational units to focus on their emerging healthcare businesses and leverage third-party services with deep experience in the space.
Contract Product Development
To compete for business and bring compliant products to market, ODMs need to understand medical device regulatory requirements in their customers' target markets, have a supporting QMS system, and in many situations effectively have the same overall RA/QA capability as a medical device company.
- Planning and designing document and data enrichment plans as part of document
management system migrations.
- Interpreting requirements for enrichment and remediation of document meta-data
• Communicate with client to collect required document information
• Investigate and clean up issues by reviewing data, including reviewing submission
• Prepares status reports, final reports and metrics for remediation activities.
- For more information contact us for a no cost, no hassle phone consultation below: