MEDICA PHARMING BV
MEDICA PHARMING BV
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  • Home
  • About Us
  • Expertise
  • Projects
  • Partners
  • Careers
  • Contact Us

Projects

Medica Pharming Consultancy BV has a proven track record of success across global pharmaceutical and biotech companies. Our consultants have led complex validation, compliance, and quality improvement projects — ensuring regulatory readiness and operational efficiency.

CAPEX Project

CAPEX Project

CAPEX Project

 Supported the configuration, qualification, and deployment of Automation Control Sysems (DCS), PLCS/SCADA and Manufacturing Execution Systems (MES) within large-scale biologics operations. 

CAPEX Project

CAPEX Project

CAPEX Project

 Computer System Validation activities for GMP manufacturing systems, ensuring alignment with Commissioning, Qualification, and Validation (CQV) processes. Oversaw integration of DCS, SCADA, MES, and OSI PI systems into a harmonized validation framework using GAMP 5 & Annex 11 principles. 

CAPEX Project

CAPEX Project

Remediation Plan

 Supported biosimilar development activities and technology transfer across CMOs, with documentation aligned to EMA and FDA expectations. 

Remediation Plan

IGJ Audit Readiness

Remediation Plan

  Supported CSV and remediation Plan-Led audit readiness and remediation plan for laboratory and manufacturing systems.

QA Support

IGJ Audit Readiness

IGJ Audit Readiness

QA support for Dydrogestrone Expansion, and OPEX processes.

IGJ Audit Readiness

IGJ Audit Readiness

IGJ Audit Readiness

IGJ Audit readioness including remediation plan and participation in front office during audit.

Remediation Plan

Remediation Plan

Remediation Plan

Supported remediation plan and audit readiness.  Conducted comprehensive ISO 17025 audits for analytical laboratories, with a focus on data integrity, instrument qualification, and method validation. 

QA R&D Support

Remediation Plan

Remediation Plan

 Supported validation of manufacturing systems and compliance of legacy equipment with new data integrity requirements. 

QA Support

Remediation Plan

QA Support

Supported Quality unit in the OPEX project.

GMP Compliance Oversight , Ensured that all activities adhered to EU GMP, FDA 21 CFR, ICH Q10, and local regulatory standards.

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