Strategic QP oversight and regulatory intelligence for global life science sector.
At Sinova Pharma, we excel in providing tailored Pharma Quality consulting services that drive strategic growth and operational success. Trust our experienced professionals to deliver precise insights and effective solutions for your business challenges.
About Sinova Pharma
Strategic Regulatory & Quality Consultancy for the Global Life Sciences Sector.
Sinova Pharma is an independent UK-based pharmaceutical quality and regulatory consultancy delivering strategic regulatory advisory, GMP audit, inspection readiness, and Qualified Person (QP) certification services across UK and EU markets, enabling organisations to maintain compliance and deliver safe healthcare products to patients.
We work with Marketing Authorisation Holders, pharmaceutical & biotech companies, CDMOs, and importers to strengthen quality systems, manage regulatory risk, and remain inspection-ready under global GMP requirements.
Our approach is independent, risk-based, and commercially aware, safeguarding regulatory integrity while supporting operational continuity.
Our Services
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Sinova Pharma provides independent Qualified Person (QP) oversight and support to pharmaceutical manufacturers and Marketing Authorisation Holders.
Our QP services include:
Batch certification oversight
Review of batch documentation and deviations
Quality oversight for outsourced manufacturing
Support for IMP release activities
Risk-based assessment of manufacturing and supply chain processes
Our approach ensures that medicinal products are released in full compliance with applicable regulatory requirements.
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We conduct comprehensive audits to assess compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards.
Audit services include:
Supplier qualification audits
Contract manufacturing organisation (CMO) audits
Distributor and GDP audits
Due diligence audits for acquisitions or partnerships
Mock regulatory inspections
Our audits provide organisations with clear, practical insights to strengthen quality systems and maintain regulatory compliance.
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Sinova Pharma supports pharmaceutical organisations in strengthening their quality systems and regulatory readiness.
Our services include:
Inspection readiness and regulatory preparation
CAPA system review and remediation
Deviation and change control improvement
Data integrity assessments
Risk management and quality system optimisation
We help organisations develop robust quality frameworks aligned with regulatory expectations.
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We deliver specialised training programmes designed to enhance the regulatory and quality knowledge of pharmaceutical teams.
Training areas include:
Good Manufacturing Practice (GMP)
Good Distribution Practice (GDP)
Quality management systems
Regulatory inspection readiness
Pharmaceutical compliance best practices
Training can be tailored to support organisations preparing for regulatory inspections or strengthening internal quality capability.
Expert consulting services tailored to your business needs, providing strategic solutions and actionable insights. Enhance performance and drive success with our seasoned professionals guiding your organization into a prosperous future.
Contact Us
Partner with Sinova Pharma
Secure your supply chain and elevate your quality standards. Whether you require expert QP oversight, comprehensive GMP auditing, or strategic regulatory guidance, our founder-led team is ready to assist.
Email: info@sinovapharma.com