compliance  +  regulatory  +  training

After working for one year as the internal audit for a medical device company, the client filled out our Client Quality Assessment form and stated: “Most of the consultant services used in the past were very specific in the scope of their activities. SCI provided general guidance through the auditing activities that provided more of a global perspective of the quality systems activities. Overall, the comments, suggestions and insight provided by SCI gave us a positive direction for improving our quality systems.”

“I have been working directly with Dr. Wagner for over two years. Carmen is extraordinarily knowledgeable in her technical field, and she is very generous in sharing this knowledge and putting it into context. Her teaching style is engaging, fun, and to the point. I particularly appreciate her keen understanding of blending legal, compliance, and technical thinking to develop workable solutions that truly consider the complexities of compliance in product development.

- Thomas Thuene, Consultant, The Quantic Group, Ltd.
worked directly with Carmen at Strategic Compliance International, Inc.

“Carmen was hired as my replacement at Lederle-Praxis Biologics (LPB) following my decision to leave the company for another opportunity. During Carmen's tenure at LPB I maintained contact with Carmen and also had the good fortune to work as her colleague with the Biologics Consulting Group. Carmen is recognized as a leader in the areas of pharmaceutical product development quality assurance.

- Larry Winberry, Senior Consultant, Biologics Consulting Group
worked directly with Carmen at Lederle-Praxis Biologics (Wyeth)

“Dr. Wagner was an excellent QA & QC director at Wyeth Lederle Vaccines, who maintained very high Quality standards as well as practical knowledge of vaccine manufacturing. She brings the same skills and high energy output to her own consulting business.”

- Thad Pullano

“Dr. Wagner's services were significantly better than other consultants I have used in over 25 years of industry employment. She provided reasonable but highly appropriate solutions which we were able to implement and that met our needs.”

- Joyce Francis