Our Services

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.

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.

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.

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.