Regulatory compliance

While everyone knows that building compliance into your organization is required, this reality is easier said than done. With the increasing globalization of manufacturing and the fluid state of regulatory expectations, industry executives are tasked with

ensuring products are made to meet stringent quality attributes no matter where they are manufactured.

So how do organizations meet these quality standards? A key component is audits, which not only identify gaps in meeting compliance aspects, allowing a proactive approach to remediate, but also aid in developing a quality culture and mindset. Compli’s experienced team will assist with this complex process. We will apply an organization’s standard procedures or customize a process to fit the organization, with the goal of meeting compliance needs.

  • Quality System Development and Remediation

  • Change Control & SOP Development Support

  • QMS – Assess, Design, Implement

  • cGMP Document Design and Development

  • cGMP Training

  • Compliance Audits: PAI, QMS & ISO

  • GAP and Risk Assessments

  • FDA Inspection Coordination and Follow-up

  • Regulatory Solutions (483, Warning Letter, Consent Decree, etc.)

  • Development, Review and Assessment of FDA Submissions (INDA, NDA, 510K & PMA)