compliance  +  regulatory  +  training
Executive Solutions - Gap Analysis/Remediation
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

SCI has an expert team that can assist you with identifying regulatory compliance gaps in your organization. Assessment audits can focus on one quality system element or can cover all manufacturing and testing operations. GMP, GLP, ISO 13485, Biosafety, Computer technology/ validation assessments can be carried out. Due Dilligence Assessments are also available.

Once the regulatory compliance gaps are identified, SCI has the right team to assist your company in the development of the right strategy and approach to resolve the compliance deficiencies. Our experts can help develop:

  • Implementation plans
  • Supporting documentation
  • Master plans and training programs

We can work side-by-side with your team to develop a plan that suits your needs and has your personal input. We can also train your workforce, if necessary.