Regulatory Compliance Associates® Inc.’s Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

Our Medical Device Quality services include:

 

Outsourced Quality Support

Interim Management, or outsourcing quality and regulatory management, has become an increasingly common practice in the life science industry. The quality assurance (QA) and regulatory affairs (RA) functions create extra complexity for large and small life science companies because needs may vary greatly depending on the lifecycle of the organization. These companies turn to outsourcing to manage operations and tactical skills and also help adopt best practices.

 

Early in a company’s lifecycle, strategic leadership is needed for​ ​product filings, regulatory pathway, manufacturing setup, and quality management systems creation. As the company matures, these functions often transition to a maintenance mode.
 
Strategic leadership is needed for​ ​product filings, regulatory pathway, manufacturing setup, and quality management systems creation.
 
Outsourcing strategic management can provide a better match to changing QA / RA strategic needs through a company’s lifecycle. Our interim management brings needed expertise while saving costs.

 

We can assist in the following situations:

 

  • Strategic Leadership and Management of the QA / RA Functional Area
  • Staff Transitions or Augmentation
  • Special Projects Lacking Internal Bandwidth
  • Early-Stage Companies Needing Strategic QA / RA Insights, but Not Ready for Full-Time Headcount

We can provide needed expertise while saving costs in areas including:

 

  • Quality
  • Regulatory
  • Operations
  • Medical Affairs
  • Product Development

Additional Quality services include:

 

  • Document Control Systems Implementation and Remediation
  • Quality System Implementation
  • Quality System Remediation
  • Risk Management (ISO 14971)
  • ISO 13485
  • 21 CFR part 820
  • Quality Due Diligence
  • Laboratory Support
    • Standard Operating Procedure (SOP) Development
    • Method Transfer
    • Method Validation

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