Reglera Corporate Introduction


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Medical Device Regulatory Consulting and Quality Systems Development and Implemenation and Outsourced Services.

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  • Intro: Introduce Reglera attendees Read intro verbatim Transition: Although these are lofty goals and aspirations, I think you will see how this simple statement is directly linked to everything we do and the outcomes we achieve. Reglera’s management team has been working in the Medical Device market space for decades. During this time we learned that there are some specific, fundamental challenges that face everyone in this industry. Key Outcomes: Introduce the purpose of our business Begin to establish credibility set the stage for the introduction of the problem set on the next page
  • Reglera Corporate Introduction

    1. 1. An Introduction to Reglera Products and Services Brian Tucker Director of Business Development [email_address]
    2. 2. Reglera LLC <ul><li>Reglera Founded in 2001 </li></ul><ul><li>Denver, Colorado Based </li></ul><ul><li>100+ Full Time Associates </li></ul><ul><li>Access to Over 200 Field Experts </li></ul><ul><li>Provide Quality Assurance and Regulatory Consulting and Outsourcing Services Worldwide </li></ul><ul><ul><li>Pre-Market Activities / Approvals </li></ul></ul><ul><ul><li>Design Control </li></ul></ul><ul><ul><li>Manufacturing Startup </li></ul></ul><ul><ul><li>Quality System Implementation and Support </li></ul></ul><ul><li>Clients Include Medical Device Manufacturers and Human Tissue Banks </li></ul>
    3. 3. Key Facts <ul><li>ISO 13485 Certified by BSI </li></ul><ul><li>One of only a few Consulting Companies ever to successfully support clearance of a Consent Decree from FDA. </li></ul><ul><li>Clearance of numerous Warning Letters and 483s </li></ul><ul><li>Inc. Magazine’s Inner City 100 for 2005 (#43) </li></ul><ul><li>First company to successfully launch Outsourcing Services for Medical Device Manufacturers </li></ul><ul><li>Privately Owned / Self Funded </li></ul>
    4. 4. Outsourcing Services <ul><li>Document and Change Control </li></ul><ul><li>Training Records Management </li></ul><ul><li>Complaint Handling / Adverse Event Reporting (MDR, MDV, CMDR) </li></ul><ul><li>Supplier and Internal Audit Programs </li></ul><ul><li>Validation Programs </li></ul><ul><li>Regulatory Submissions </li></ul><ul><ul><li>513(g) </li></ul></ul><ul><ul><li>Pre-IDE </li></ul></ul><ul><ul><li>IDE </li></ul></ul><ul><ul><li>Request for Designation (RFD) for Combination Products </li></ul></ul><ul><ul><li>510(k) </li></ul></ul><ul><ul><li>PMA </li></ul></ul><ul><ul><li>Canadian License Applications </li></ul></ul><ul><ul><li>EU Technical Files / Technical Dossier </li></ul></ul>
    5. 5. Consulting Services <ul><li>Route to Market - FDA Strategy </li></ul><ul><li>Regulatory Filings – 510k & PMA </li></ul><ul><li>Quality System Design & Implementation (QSR & 13485 </li></ul><ul><li>Gap Assessments – FDA, ISO 13485 & 9001 </li></ul><ul><li>Audit Preparation & Support – FDA & ISO </li></ul><ul><li>Regulatory/Quality Training </li></ul><ul><li>Design Controls </li></ul><ul><li>Validation Projects </li></ul><ul><ul><li>Equipment </li></ul></ul><ul><ul><li>Software </li></ul></ul><ul><ul><li>Processes </li></ul></ul><ul><ul><li>Environmental Controls </li></ul></ul><ul><ul><li>Sterilization </li></ul></ul><ul><li>Corrective and Preventive Action </li></ul><ul><li>483/Warning Letter Remediation </li></ul>
    6. 6. A New Consulting Model <ul><li>Integration of Business Strategy and Quality System </li></ul><ul><li>Defined Deliverables and Outcomes </li></ul><ul><li>Fixed Bid Pricing for Specified Elements </li></ul><ul><li>Bias for Action not Advice </li></ul><ul><li>Direct Management of Outsourced Functions </li></ul><ul><li>Project Resource to Develop and Implement Systems </li></ul><ul><li>Capacity to Supply On-going QA Management </li></ul>
    7. 7. Virtual Company Solutions <ul><li>Total Outsourcing for Startup Companies </li></ul><ul><ul><li>Regulatory Affairs </li></ul></ul><ul><ul><ul><li>Route to Market - Strategy Development </li></ul></ul></ul><ul><ul><ul><li>Regulatory Submissions </li></ul></ul></ul><ul><ul><li>Design Control </li></ul></ul><ul><ul><ul><li>System Development and Implementation </li></ul></ul></ul><ul><ul><ul><li>Complete Execution Support </li></ul></ul></ul><ul><ul><ul><li>DHF / Technical File Assembly </li></ul></ul></ul><ul><ul><li>Quality Systems Development </li></ul></ul><ul><ul><ul><li>Quality Manual </li></ul></ul></ul><ul><ul><ul><li>Quality System Procedures (SOPs and WIs) </li></ul></ul></ul><ul><ul><ul><li>Complete Implementation Support </li></ul></ul></ul><ul><ul><ul><li>Management Review </li></ul></ul></ul><ul><ul><li>Outsourcing Solutions </li></ul></ul><ul><ul><ul><li>Document Control / Training Records Management </li></ul></ul></ul><ul><ul><ul><li>Complaint Handling and MDR / MDV / CMDR Reporting </li></ul></ul></ul><ul><ul><ul><li>Corrective and Preventive Action System </li></ul></ul></ul><ul><ul><ul><li>Supplier Quality Assurance Management </li></ul></ul></ul><ul><ul><ul><li>Internal Audit Implementation </li></ul></ul></ul><ul><ul><ul><li>Validation Program Design and Execution </li></ul></ul></ul>
    8. 8. Why Reglera? <ul><li>Expertise </li></ul><ul><ul><li>Proven track record in bringing new companies/products to the market </li></ul></ul><ul><ul><li>Skill in managing FDA relationships at all levels. </li></ul></ul><ul><li>People </li></ul><ul><ul><li>Excellent senior staff leveraged across numerous projects </li></ul></ul><ul><ul><li>Staff backgrounds in all areas of RA/QA - includes ex-FDA investigators </li></ul></ul><ul><ul><li>Cost effective application of the right level resources </li></ul></ul><ul><ul><li>Project team assembled based on specific work requirements </li></ul></ul><ul><li>Processes </li></ul><ul><ul><li>Reglera Proprietary Information - Access to large library incorporating industry Best Practice </li></ul></ul><ul><ul><li>Outsourcing Services </li></ul></ul><ul><ul><li>Worldwide focused organization monitoring Regulatory trends </li></ul></ul><ul><li>Commitment to Deliver Results </li></ul>