I focus on ensuring the safety and effective pharmaceutical, biotech, and medical device products through quality assurance system development and management.

I offer three ways to bring my experience and expertise into your company: pre-packaged solutions, mentoring, and conventional consulting.

Please review the options below and contact me regarding which works best for you.

3 Paths to a Quality Systems Program


“In-the-Box” Solution – prepackaged solutions 

Type of Company or Project: The Do-It-Yourselfer. You need guidance and information, and want a template that can be used as is by adding a company name and/or self-customizing.

How it is delivered:

  • Instantly downloadable and easily customizable PDFs, Word, PowerPoint and Excel Documents.
  • Available as a single procedure or topic or as a complete set of quality system programs.
  • Notes, suggestions, and advice are included with each procedure.

Contact with Cinta: None


 Circle of Training – Mentoring

Type of Company or Project: Start-up companies or single project/process initiatives which want some training and mentoring but do not want a complete consulting engagement. This is an economical option support your current staff with the knowledge and support of a senior professional.

How it is delivered: In addition to receiving the applicable procedures from the “In-The-Box” solution(s) above, individual or group training and coaching is provided.

Learn how to

  • Implement a Quality System
  • Manage and maintain compliance
  • Work through specific processes such as design control, risk analysis, audits, and supplier management

Contact with Cinta: Medium 


“Out-of-the-Box” (Consulting)

Type of Company or Project: Start-ups and established companies which want a hands-on and customized approach, from setting up of a customized Quality System through development of documents for your project, to final implementation and training.

Representative, previous projects are listed below:

  • Mock FDA audit
  • Clinical Audit of the CRO and TMF
  • Quality System Internal Audit
  • Supplier Audits
  • Batch Record Review and Release
  • Stability Protocol and Report review, including expiration dating
  • Design Control Management and Training
  • Risk Analysis and Risk Management
  • Validation Support
  • Deviations and non-conformances
  • Corrective Actions
  • Complaint Management
  • Recalls and regulatory compliance

How it is delivered. In addition to receiving the applicable procedures from the “In-The-Box” solution(s) above, individual and group training, hands-on work and deliverables are provided virtually or at the facility, as appropriate.

Contact with Cinta: High