confidence in quality
Our consultants' areas of expertise include, but are not limited to:
- Strategy Development and Strategy Execution for Technical (CMC) Development and Manufacturing from pre-clinical to commercial manufacturing.
- Technical (CMC) Development from discovery to pre-clinical, to Investigational New drug Application submission.
- Technical (CMC) Development post regulatory clinical trial approval to early and late stage clinical, to commercial development.
- Project Management of Technical (CMC) Development, Clinical Supply Management and Supply Chain Management.
- Quality Control (QC) Management, Quality Assurance (QA) Management, Quality Management Systems, Qualified Person Services and Compliance Management.
- Engineering and Facilities Project & Program Management.
- Laboratory Controls and Data Integrity Assessment.
- Interim Executive Leadership.
Getting each product to market
Each new research project in the life sciences has the potential has the potential to create life changing technologies. Getting from initial research to manufacturing and market release has its obstacles. PharmAcquaint consultants may work to overcome these obstacles through:
- Biosimilarity Assessments
- Interim reviews of both research & manufacturing, and data compilation for submission to regulatory bodies
- Identification of gaps, their criticality and impact assessment
- Potential buyer, vendor, labelling and promotion agency identification and tendering
- Project rescue after attrition or major deviations in the production process