OUR SERVICES
Quality and GxP Compliance from drug development to clinical success
How we can help
Phase-appropriate Quality and GxP compliance tailored to your organizations’ needs and corporate goals
Unlock the power of scalable Quality Management Systems tailored to your organization's unique needs. From documentation management to electronic document systems, we provide solutions that grow with your business.
Scalable Systems
Ensure the reliability and compliance of your GxP partners through our rigorous vendor qualification and oversight processes. Collaborate seamlessly with CDMOs, CROs, and other stakeholders to uphold quality standards.
Vendor Qualification
Navigate the ever-evolving regulatory landscape with confidence. Our expert team offers comprehensive regulatory affairs and compliance services to keep your operations aligned with global standards, including support with IND, CTA, and NDA submissions.
Regulatory & Compliance
Ensure adherence to high quality standards and global GxP regulations with our meticulous auditing services. From in-person to virtual audits, we provide thorough assessments to uphold the highest quality and compliance levels.
GxP Auditing
Scalable Systems
Cadoret Global specializes in designing and implementing phase-appropriate quality management systems tailored to your organization's specific requirements. With a deep understanding of industry best practices and emerging technologies, we collaborate closely with our clients to develop innovative solutions that support their long-term objectives. Our team of experienced professionals combines technical expertise with a client-centric approach, ensuring seamless integration and minimal disruption to your operations. By partnering with Cadoret Global, you can leverage scalable systems to drive growth, enhance agility, and future-proof your business for continued success.
What we offer:
Documentation Management
Comprehensive Training Programs
Standard Operating Procedures (SOPs) Library
Electronic Document Management Systems (EDMS)
Vendor Oversight
Cadoret Global offers comprehensive vendor qualification and oversight services designed to mitigate risks and optimize collaboration with your partners. Our team of experts conducts thorough assessments to ensure that your vendors meet the highest standards of quality and compliance. By leveraging our extensive industry experience and regulatory expertise, you can trust Cadoret Global to identify potential risks, establish quality agreements, and streamline vendor relationships. With Cadoret Global as your partner, you can rest assured that your vendors are qualified, reliable, and aligned with your organization's objectives.
What we offer:
Collaborative partnership with CMC/CDMO teams
Quality Agreements negotiation
Review of Master and Executed Batch Records
Oversight of Deviations, CAPA, Investigations, and Complaints
Technology and Analytical Method Transfers management
Product Disposition assurance
Supervision of Stability Studies
GXP Auditing
Cadoret Global offers comprehensive GxP auditing services designed to help organizations maintain compliance with regulatory requirements and industry best practices. Our team of experienced auditors conducts rigorous assessments of your operations, identifying potential non-compliance issues and providing actionable recommendations for improvement. Whether you require routine audits, pre-inspection assessments, or remediation support, Cadoret Global has the expertise and resources to meet your needs. With our thorough approach and attention to detail, you can entrust Cadoret Global with the audits of your GxP partners.
What we offer:
Foreign and Domestic, in-person, hybrid, and virtual audits of:
Contract Development and Manufacturing Organizations (CDMOs)
Packaging, Labeling and Distribution Facilities
Clinical Research Organizations (CROs)
Clinical Sites & Phase I Units
Software as a Service (SaaS) Vendors
Regulatory & Compliance
Cadoret Global offers comprehensive regulatory affairs and compliance services tailored to the unique needs of your organization. Our team of regulatory experts provides strategic guidance and practical solutions to help you navigate the regulatory landscape with confidence. Whether you're seeking regulatory strategy support or guidance on communicating with regulatory agencies, Cadoret Global can provide regulatory advisory services to meet your needs and ensure compliance is at the forefront of your organization.
What we offer:
IND / CTA / NDA preparation support
Regulations Risk Assessment
Right-Sized Privacy Compliance
Data Protection, Privacy & Security
Let’s Connect.
Explore how Cadoret Global can support your organization’s transition from pre-clinical to clinical
Our guiding principles
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We collaborate and communicate effectively with your organization and those you work with.
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Our team understands and is ready to meet the variable and rushed demands of the development lifecycle.
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At Cadoret Global, we know how to wear multiple hats and assist our Clients with prioritization of work.
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Our niche is to give companies a hand in setting a foundation for success through procedures, processes and scalable, phase-appropriate systems.
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We are willing to go the extra mile for your success. Every. Time.
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We have proven experience in helping companies like yours lay the foundation for Quality and Compliance from the get-go.
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At Cadoret Global, we know deliverables and timelines impact the bottom line, and prioritize accordingly.