Inglasia
Inglasia Pharma Solutions is dedicated to meeting the quality needs of pharmaceutical and biotechnology clients by providing expert GMP and GDP consulting services. They support clients in achieving compliance with global regulatory standards, optimizing quality management systems, and ensuring the safety and efficacy of medicinal products and medical devices. Their services include quality assurance, change management, regulatory inspection readiness, vendor management, and specialized training, all aimed at enhancing operational excellence and regulatory compliance in the pharmaceutical industry.
Industries
Nr. of Employees
small (1-50)
Inglasia
Products
Services catalogue (PDF)
Downloadable catalogue describing available quality and compliance services.
GMDP Vendor Management Process Flow (DOCX)
Process-flow document describing supplier management steps for GMP/GDP vendors.
Media Fill Failure Process Flow (PDF)
Process-flow PDF for expedited investigation of media-fill failures in aseptic operations.
GxP Training Management (PDF)
Framework and process-flow PDF for managing GxP training from onboarding to offboarding.
Training and guidance videos (YouTube)
Recorded training content covering topics such as GMP introduction, deviation investigations, inspection readiness and GDP audit priorities.
Services catalogue (PDF)
Downloadable catalogue describing available quality and compliance services.
GMDP Vendor Management Process Flow (DOCX)
Process-flow document describing supplier management steps for GMP/GDP vendors.
Media Fill Failure Process Flow (PDF)
Process-flow PDF for expedited investigation of media-fill failures in aseptic operations.
GxP Training Management (PDF)
Framework and process-flow PDF for managing GxP training from onboarding to offboarding.
Training and guidance videos (YouTube)
Recorded training content covering topics such as GMP introduction, deviation investigations, inspection readiness and GDP audit priorities.
Services
Introductory consultancy session to discuss quality needs and potential scope of support for GMP/GDP topics.
End-to-end QMS services including process mapping, SOP and template development, testing, review and embedding into business operations.
Conducting GMP/GDP audits for internal operations and third-party suppliers, including reporting and remediation planning.
Training and preparation for regulatory authority inspections covering documentation, personnel conduct, and readiness checklists.
Supplier qualification, initial onsite audit recommendations and drafting Quality Technical Agreements to align vendor operations with client QMS.
Support in performing structured deviation investigations, documentation of findings and implementation of corrective and preventive actions.
Introductory consultancy session to discuss quality needs and potential scope of support for GMP/GDP topics.
End-to-end QMS services including process mapping, SOP and template development, testing, review and embedding into business operations.
Conducting GMP/GDP audits for internal operations and third-party suppliers, including reporting and remediation planning.
Training and preparation for regulatory authority inspections covering documentation, personnel conduct, and readiness checklists.
Supplier qualification, initial onsite audit recommendations and drafting Quality Technical Agreements to align vendor operations with client QMS.
Support in performing structured deviation investigations, documentation of findings and implementation of corrective and preventive actions.
Expertise Areas
- GMP/GDP compliance
- Quality Management System design and implementation
- Regulatory inspection readiness
- Vendor qualification and supplier management
Key Technologies
- Quality Management Systems (QMS)
- Temperature mapping studies
- Thermal packaging for cold chain
- Unique Device Identification (UDI) systems
News & Updates
An overview of how to create an effective change management process within pharmaceutical companies.
Guidance on what makes a good quality auditor and tips for conducting effective audits.
Discussion on the effectiveness of existing quality management systems and how to improve them.
Guidance on transitioning from MDD to EU MDR and compliance requirements.
Support for pharmaceutical startups in implementing and maintaining QMS.
Insights into common practices in the pharmaceutical industry.
An overview of how to create an effective change management process within pharmaceutical companies.
Guidance on what makes a good quality auditor and tips for conducting effective audits.
Discussion on the effectiveness of existing quality management systems and how to improve them.
Guidance on transitioning from MDD to EU MDR and compliance requirements.
Support for pharmaceutical startups in implementing and maintaining QMS.
Insights into common practices in the pharmaceutical industry.