Consulting Services

Decades of pharmaceutical industry experience has provided our consultants with the ability to provide efficient and effective solutions to your compliance issues. We offer not only tried and true solutions but also have the experience to create a highly customized solution which fits your company's unique situation. Some of our areas of expertise include:
  • Design and re-engineering of Quality Systems for compliance to 21 CFR 210/211 and 820 regulations, or ISO9001 and ISO13485 standards.
  • Documentation of regulated manufacturing processes including authoring of Chemistry and Manufacturing Controls (CMC) sections of Drug or combination Drug / Device Regulatory Submissions.
  • Qualification projects for manufacturing equipment, laboratory instruments, clean rooms and water systems.
  • Validation projects for analytical methods and manufacturing processes including water system and cleaning validation.
  • Quality improvement projects for manufacturing and administrative processes using Six-Sigma and Lean tools.
  • Experimental design and data analysis projects to assist with your company's investigations and CAPA efforts.
  • General company wide training in GMPs or highly focused training for a small group of individuals in a specific functional area of GMP Quality Assurance and regulations.