Developing a Regulatory Strategy
to meet Global Health
Authority Requirements

Regulatory Solutions

QSC Inc. provides seasoned professionals who strive to ensure that your Regulatory programs are in compliance with health authority regulations. Health Authority inspections can result in serious consequences that can be costly to remediate, create delays for new product to the market, and have an adverse impact on shareholder value. We help our clients manage risk effectively resulting in minimized regulatory exposure and ultimately reducing adverse impact to your business.

QSC consultants have experience in global product development and can partner with your company’s project teams to develop and execute a solid product development strategy. QSC can assist your company in the design and development of compliant, cost effective regulatory submissions, which can minimize the delays associated with product development and market expansion.

QSC Inc. offers the following Regulatory Solutions:

Compliance & Risk Management

  • FDA and International Regulatory Agency Inspection Preparedness
  • PAI Inspection Readiness
  • FDA Warning Letter and Consent Decree Remediation
  • Data Integrity Audits, Product Quality Assessments, Third Party Quality Oversight

Regulatory Strategy Development (all phases of project lifecycle)

Submission Design & Development

Regulatory Liaison Management