Nicholas Lowther
Biography
N Lowther Consulting Ltd offers independent, expert, CMC consulting services to the pharmaceutical industry. Services range from strategic technical advice, project planning, troubleshooting and outsourced technical project management to compilation of CMC sections of regulatory submissions and technical due diligence activities.
I have over 30 years' experience in the pharmaceutical industry, having spent 17 years in big pharma, followed by 13 years in the 'virtual development' and consulting arena. I have worked with many, varied, EU, US and Asia (Japan, Taiwan, Korean)-based clients ranging from small biotech, through small pharma, mid-sized pharma to big pharma and am very familiar with the challenges that need to be addressed in early development and the approaches required to meet budget and deadlines. I have a strong network of CMOs/CROs and am well versed in outsourcing of technical development activities.
| Qualifications |
BSc PhD CChem MRSC |
|---|---|
| Areas of Expertise |
Manufacturing Science, engineering and technology Strategy and policy |
| Services Offered |
Drug discovery Manufacturing and process development Analytical, forensic and laboratory services Regulatory, legal and compliance |
| Markets Served | Pharmaceutical and medicinal |
| Geographic Regions Served |
UK Europe |
Contact Nicholas Lowther
Additional information
- Candidate selection and developability assessment
- Elaboration of technical project strategies
- API development and manufacture
- Pre-formulation and dosage form design
- Dosage form development and manufacture
- Analytical development
- Physico-chemical characterisation (including solid state form selection)
- CMC project management via use of CMOs.
- Technical problem solving
- Due diligence assessments
- Compilation of CMC sections of regulatory dossiers