Services
Pharmaplaz provide a range of services to the health care industry including:
Manufacturing
- Blending
- Tableting
- Buccal Melt
- Freeze Drying
- Encapsulation
- Packaging
- Polymer extrusion
- Injection moulding
- Early stability testing
- Engineering trials
- Formulation development
- Small bench stage projects
- Process optimisation
- Formulation optimisation
- Process validation
- Scale up
- Transfer of technology
- Process critical parameter identification
- Clinical trial manufacture
- Packaging
- Scale up project management
- Commercial product manufacture
Laboratory
- Method Development
- Method Validation
- Method Transfers
- Protocol Development
- ICH Stability Storage & Analysis
- Cleaning Validation
- Finish Product Release Testing
- Raw Material Analysis
- Synthetic Route Development
Stability
- cGMP stability testing service
- -5 Degrees C, Storag
- -25 Degrees C / 60% RH, Storae
- -30 Degrees C / 65% RH, Storag
- -40 Degrees C / 75% RH. Storag
- Customised storage conditions can also be achieved
- Storage chambers qualified and validated
- 24 hour monitoring of conditions with chart records
- Backup generator for emergency power
Overall Capabilities
- Package engineering and design
- Material logistics
- Primary packaging
- Secondary packaging
- Labelling and assembly
- Supply chain management
- Stability packaging
- Analytical support
- Team based project management
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Expertise
Pharmaplaz is a complete healthcare solutions provider operating from its state of the art facility in Athlone, Ireland. Pharmaplaz is committed to advancing customer service requirements to
The Pharmaplaz team provide tailor-made support through provision of expertise in the areas of:
- Formulation & Process development
- Process scale up & validation
- Technology Transfer
- Technology development
- Analytical services
- Product Stability
- Clinical Trial Manufacture
- Packaging
- Polymer extrusion
- Injection Moulding
- Regulatory
- Commercial manufacture
- Healthcare R&D
- Project management
Clinical Trial Manufacture and Packaging
Pharmaplaz hold an Investigational medicinal product licence from the Irish Medicines Board, which meets the requirements of the European clinical trials directive 2001/20/EEC effective since
To better serve your clinical supply needs, our analytical, clinical manufacturing and clinical supply teams work together to provide a quality, seamless continuum for your product's path tow
Quality Assurance & Regulatory
- A superior quality and regulatory culture
- Qualified person
- Quality and regulatory experience in FDA environment
- Staff training in all aspects in Operations
- Demonstrated compliance with EMEA and IMB
- ISO 9001:2000 Quality Management Systems accreditation
- Regulatory support and submissions
- Licensed to handle controlled substances
- Drug Master File requirements
- IND and NDA submissions
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