compliance  +  regulatory  +  training
Executive Solutions - Strategic Planning
 
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

Entrepreneurs and business managers are often so preoccupied with immediate issues that they lose sight of their ultimate objectives. This is even more noticeable with regard to Quality/Regulatory Compliance planning, since most business managers lack exposure to regulatory policies and requirements. However, in a regulated environment, regulatory strategic planning determines where a pharmaceutical business and the quality organization are going over the next year or more, and how the company is going to get there - simply put, it helps define how fast the company will achieve success in its product development ventures.

SCI, Inc. can assist your company with:

  • Developing the successful approach and strategy to establish an effective quality organization
  • Development of the regulatory strategy
  • Workforce development
  • Planning of the quality system and supporting documentation
  • Integrating the regulatory strategy into the overall business plan, and prepare regulatory submissions

SCI can partner with your senior management team to develop and, if necessary, implement an action plan.