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Regulatory Compliance Statement

The landscape for the Life Sciences industry has become increasingly challenging. Exploding development and launch costs in a more competitive environment compel Life Sciences companies to accelerate the pace of new discovery and product launches.

Deploying technologies for automating clinical data collection and analysis, preparation of submissions, and managing manufacturing processes and resultant data are critical to the success of your business. Meanwhile, the FDA has become increasingly rigorous in its oversight and enforcement of 21 CFR Part 11 and its application to FDA rules including cGLP, cGMP, and cGCP regulations. Complying with these regulations is an imperative, not an option.

Companies must have the proper provisions, policies and tools in place to ensure that these regulations are being met both with new technology deployments and existing systems.

FDA regulations have an operational impact in many areas of the organization. With that come opportunities, as well as significant business risks. Without a compliance plan in place and a rigorous program to ensure execution, your organization is more vulnerable to FDA scrutiny, leading to delayed pre-market approvals, interruptions in manufacturing and significant penalties, not to mention the impact FDA actions can have on shareholder value and industry reputation. Compliance with FDA regulations needs to have board-level urgency in today’s Life Sciences business environment.

What We Offer

Ulmbeziers Consulting has the experience to help you develop the right approach to meeting regulatory compliance. We work with you to build and execute a compliance strategy that will enable you to utilize and implement technology to increase revenue and profitability in an environment that is compliant with FDA standards. Our solutions and services include:

Planning and Management
  • Regulatory Compliance Policy Definition
  • Development of Master Validation Plan
  • Regulatory Compliance Training
  • Program/Project Management
  • Change Management
  • Site Surveys
  • Initial Assessments
  • Gap Analysis
  • Risk Assessments
  • Vendor/CRO Audits
  • Remediation Strategy and Planning
  • Actionable Remediation Plan
  • Security Assessments
  • Business Process Design and Documentation
  • Requirements Gathering and Documentation
  • Quality/Test Team Requirements Reviews
  • SDLC Review
  • SOP Documentation
  • Training
  • Validation Protocol Design and Documentation
  • Manual and Automated Application Testing
  • Code and Unit Testing
  • Release Engineering
  • Revalidation Program
  • Validation after Change
Ongoing Operations and Maintenance
  • Periodic Gap Assessments
  • Supplier and Contractor Audits
  • Software Process Assessments and Improvement Initiatives
  • Quality System and Part 11 Training
  • Application Training
  • Ongoing Project Management