what we do
About Our Services
Delivering the highest quality pharmaceutical solutions
Formulation, Development, and Optimisation
Technology Transfer and Scale Up including Regulatory Support
Auditing and Quality Services
Equipment and Plant Qualification
Cosmetic and Cosmeceutical Regulatory Strategy
Formulation, Development, and Optimisation
- formula development
- product reformulation and optimisation
- advising on design of experiments
- granular flow studies
- All pharmaceutical dosage forms including but not limited to extrusion and spherisation
- Instant release, Modified release technologies
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Aqueous Tablet colour coating; sugar colour, controlled release and taste masking
- Process validation and optimisation for all dosage forms
- Manage labscale activities to support formulation and process for scale up
- Medical Devices certification, MDR, MMD updates
- Micronisation technology
- Pharmaceutical Product transfer manufacturing, analytical methods and quality systems
- technology transfer play book initiation and coordination
- Due diligence – Site readiness capability assessment to accept transfer
- Provide and support justifications with expert reports for change variations
- Propose Process Capability Improvements
- Cost improvement programs for manufacturing processes
- General Troubleshooting
- Coordinate Comparative dissolutions for site-to-site transfers
- Coordinate Analytical and Microbiological testing for stability
- Stability planning strategies
- Process validation and optimisation planning for all dosage forms
- manage full site transfer plan
- Alternative suppliers review and implementation for a continuous supply chain
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Regulatory response writing, including dossier section updates
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Experience in pharma, OTC, veterinary, and food supplement regulatory environments
Technology Transfer and Scale Up
including Regulatory Support
Technology Transfer and Scale Up
including Regulatory Support
- Pharmaceutical Product transfer manufacturing, analytical methods and quality systems
- technology transfer play book initiation and coordination
- Due diligence – Site readiness capability assessment to accept transfer
- Provide and support justifications with expert reports for change variations
- Propose Process Capability Improvements
- Cost improvement programs for manufacturing processes
- General Troubleshooting
- Coordinate Comparative dissolutions for site-to-site transfers
- Coordinate Analytical and Microbiological testing for stability
- Stability planning strategies
- Process validation and optimisation planning for all dosage forms
- manage full site transfer plan
- Alternative suppliers review and implementation for a continuous supply chain
-
Regulatory response writing, including dossier section updates
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Experience in pharma, OTC, veterinary, and food supplement regulatory environments
Auditing and Quality Services
- Experienced international auditors
- Qualified and responsible persons
- Audits covering Active pharmaceutical ingredients, excipients, packaging, all dosage form GMP facility inspections, pharmaceutical warehousing, laboratories, transport
- Providing CAPA’s and formal reports
- Audit readiness training, perform pre-audits, post-audit response planning
- QMS – quality management systems implementation
- Provide training in core principles GMP, GDP, GLP or GCP
- Root cause analysis, process investigations and training
- QP training and coaching for roles and responsibilities
- Compliance gap analysis, ensure manufacturing sites comply to dossier and pharmacopeia updates
- Raw Material, API qualification support
- Drug master file review
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Troubleshooting and investigations
- Propose fit for purpose equipment for manufacturing sites and lines
- Equipment onboarding/installation plans: qualification validation
- Manufacturing, packaging and plant equipment FAT and SATs
- Expert on PUWER (Provision and Use of Work Equipment Regulations) and OEE (Overall Equipment Effectiveness) assessments
- Expert in planned and quality maintenance using proactive and preventative techniques
Equipment and Plant Qualification
Equipment and Plant Qualification
- Propose fit for purpose equipment for manufacturing sites and lines
- Equipment onboarding/installation plans: qualification validation
- Manufacturing, packaging and plant equipment FAT and SATs
- Expert on PUWER (Provision and Use of Work Equipment Regulations) and OEE (Overall Equipment Effectiveness) assessments
- Expert in planned and quality maintenance using proactive and preventative techniques
Cosmetic and Cosmeceutical Regulatory Strategy
- Manufacturing Process Development and Optimisation
- Cosmetic and Cosmeceutical Regulatory Affair
- Process, Packaging and Cleaning Validation for a variety of cosmetics
- Formula Development
- Product Reformulation
- Chemical and Microbiological Testing
- Site Transfer Management