How We Can Help Your Medical or Pharmaceutical Firm

Quality System Implementation

Our consultants have had years of experience developing and implementing quality systems that are compliant with both domestic and international regulations. They can work directly with your employees to implement a process that will meet your specific organizational needs. Let us help your organization prepare and implement your process validations.

Seminars/Training

Our consultants are experienced in conducting a host of general and personalized training sessions. Some examples of past seminars include:

  • Design Control for Medical Devices
  • Principles of Process Validation
  • Quality System Regulation (QSR)
  • ISO 13485
  • Managing Regulatory Inspections
  • Performing Risk Analysis
  • Effective Quality Assessments
  • Regulatory Overview for Medical Devices
  • Quality System Inspection Technique

Regulatory Compliance/Submissions

Knowledgeable and experienced in FDA medical device quality system requirements (QSR), Product Design Control, Product Documentation, Internal Audits, Drug cGMPs, European Medical Device Directive (MDD), ISO 9000 quality standards, 510(k) and NDA submissions, Facility Registrations and Device Listings.

Project Management

Our consultants have experience in the implementation of over 1400 new products and 4000 product transfers. Let our consultants help you develop a team approach to product development and market introduction. From establishing the team, to identifying the timeline, to communicating results, to production implementation, we can expedite your projects for quicker results.

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