What We Do

Chemical | Pharmaceuticals

Facility & Equipment

Cleanroom Validation & Maintenance

Assess overall compliance level of a classified cleanroom. Develop Cleanroom Qualification, Maintenance and Environmental Monitoring Program

System Inventory & Assessment

Assess, identify gaps and build equipment inventory, spares inventory, minimize downtime

Equipment Maintenance Strategy

Development & optimisation of equipment maintenance & monitoring

System Validation

This includes Equipment Validation, Computer System Validation, Design Qualification (DQ), Installation Qualification (IQ), Operational qualification (OQ), Performance Qualification (PQ) & Validation Reports

Manufacturing Process

Interim Functional Leadership

We can provide expertise & leadership while you develop your team

Troubleshooting

Methods to remediate process & test failures

Comparability Studies

Streamline future regulatory needs with a bespoke roadmap

Product and process development planning

Development of comprehensive process & product roadmap

Process Codification

Process Definition to meet regulatory requirements

Process Evaluation

Clarify process performance & trends

Analytical Method Lifecycle

Stability Study Design

Optimal’s stability study design ensures product quality and compliance throughout Chemical and Pharmaceuticals industries.

Comparability Testing

Design strategy to enable establishment of comparability to ensure that manufacturing changes are compliant

Method Transfer & Remediation

Hand carry defined analytical methods to their new home

Qualification & Validation

Design Protocols, oversee method qualification / validation studies

Specification Setting

Identify product Critical Quality Attributes

Method Development

Identify & select appropriate analytical methods

Quality Assurance

QP Support

Global support from QPs with expertise in Global regulatory standards

Audits

Execution of a phase-appropriate audit program

Supplier Oversight

Supplier Evaluation, Risk Assessment

Document Authoring, Review & Revision

Produce SOPs, Policies, Controlled Documents

QMS Gap Assessment

Analyse QMS & Provide phase appropriate solutions

QMS Design

Quality Management System development

Our Clients

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