OriPeutic BioServices CREATES SOLUTIONS THAT HELP YOU MEET EACH COMPLIANCE REQUIREMENT

OriPeutic BioServices is a trusted and experienced partner who can help you identify problems and implement solutions to meet compliance requirements. Our seasoned experts, who have agency experience, will work with you and your staff on the shop floor and in the board room to help you proactively avoid future compliance problems.

REPOSITIONING COMPLIANCE

Our experts will work with you to address compliance issues by repositioning compliance as an integral part of your overall value chain, thus minimizing potential damage to your firm from regulatory observations and actions.

• cGMP/ cGLP, cGCP Assessments including general cGMP inspection readiness, PAI readiness, facility and equipment design, CFR21 PART 11 compliance, data integrity assessments, and due diligence assessments.

• Remediation Support, including review of responses and support for remediation in response to FD483 observations, warning letters, or consent decrees, including independent third-party review of deviation investigations, change controls, validation reports, laboratory investigations, method validation reports, etc.

• Quality Systems Assessments include quality, production, laboratory controls, facilities and equipment, materials, and packaging and labeling systems.

DELIVERING SUSTAINABLE RESULTS

The OriPeutic BioServices team will work side-by-side with your team to assess your processes and systems, identify gaps,  and raise your level of compliance through the life cycle and across your entire business. We mentor and coach along the way and provide knowledge transfer so your team can sustain the new working method.