FDA/ISO Regulatory Consulting Services

Companies developing new products are required to perform clinical studies to generate data to support FDA pre-market approval. A growing number of companies turn to MDC Associates for expert guidance in conducting and monitoring clinical studies and obtaining FDA approval.

With so much at stake with a product launch or maintaining regulatory requirements for existing products, it makes sense to navigate the rigorous regulatory maze with a company that has successfully done it for over 25 years.

Three-tier approach
MDC Associates takes an effective three-tier approach to quality system compliance and obtaining CE mark or FDA clearance:

  • Developing and implementing an effective regulatory strategy through the product lifecycle
  • Planning and monitoring clinical trials
  • Planning and monitoring analytical studies, including risk analysis
  • Providing all the support and guidance necessary to move through the entire regulatory review and approval process

MDC Associates has the experience and skills to:

  • Register company with FDA
  • Prepare facility and documentation required for FDA, QSR, cGMP, CMDCAS, MDD, IVDD and ISO 13485 compliance
  • Monitor quality systems for continual regulatory compliance
  • Develop and conduct regulatory training programs
  • Develop clinical and analytical study protocols
  • Conduct clinical trials
  • Prepare pre-market submissions
  • Conduct facility audits
  • Provide aftermarket product service and support

Regulatory obligations being met
MDC Associates prepares on average five to ten FDA pre-market submissions per year. All have been cleared by the FDA, and have benefited from an average time to product approval of between 80-120 days.

In addition to obtaining clearance for professional products, MDC Associates has conducted clinical trials for clients selling Over-the-Counter (OTC) products, and successfully submitted several of these products for FDA clearance. MDC has also been effective in obtaining CLIA waiver for several IVD products.

Important work being done
MDC Associates was awarded a contract by the Centers for Disease Control and Prevention (CDC) to conduct clinical trial in the area of HIV point-of-care confirmation testing. This study has been recognized as one of the more important clinical trials for HIV conducted by the CDC.

RegulatoryCase Study