Compliance Consulting OriPeutic BioServices Delivers Practical, Sustainable Compliance Solutions

At OriPeutic BioServices, we don’t just check boxes—we help you embed compliance into your value chain to protect your products, your patients, and your business. Our seasoned consultants—many with prior experience at regulatory agencies—work closely with your team, from the shop floor to the boardroom, to help you identify gaps, implement sustainable improvements, and proactively manage regulatory expectations.

 

Compliance as a Strategic Advantage

We believe that compliance isn't a burden—it's an asset. By repositioning compliance as a core business function, we help reduce the risk of FDA 483s, warning letters, consent decrees, and costly remediation efforts. Our experts tailor solutions to your specific operations and help establish a lasting compliance culture.

 

Our Compliance Expertise

GxP Compliance Assessments

• cGMP, cGLP, and cGCP audits

• Inspection readiness (routine, PAI, and for-cause)

• CFR 21 Part 11 and data integrity reviews

• Facility, equipment, and documentation assessments

• Due diligence and acquisition risk assessments

Remediation & Response Support

• FDA 483 and warning letter response review and support

• Consent decree gap assessments and remediation planning

• Independent review of deviations, investigations, CAPAs, and validation

• Laboratory data integrity and method validation oversight

• Change control and risk assessment documentation support

Quality System Assessments

• Evaluation of quality, production, and lab control systems

• Assessment of facilities, equipment, materials, packaging & labeling

• Alignment with FDA 21 CFR Parts 210/211, 820, 58, and ISO 13485 standards

• Identification of systemic issues and process improvement opportunities

How We Work

• Hands-On Support – Our team works in your environment, learning your systems and collaborating directly with your staff.

• Knowledge Transfer – We train, coach, and mentor your team to own and sustain improvements.

• Rooted in Experience – Many of our consultants are former FDA, EMA, or global regulatory professionals.

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Sustainable Compliance, From Assessment to Execution

At OriPeutic BioServices, our mission is to strengthen your compliance posture—not just for your next inspection, but for the long-term. We ensure that your team has the tools, insights, and support to maintain excellence across your operations.