NanoClimate
NanoClimate is a leading pharmaceutical and biotechnology consulting firm specializing in regulatory, CMC product development, technology transfer, and quality systems. They focus on helping clients navigate complex regulations, ensure quality, and bring products to market efficiently. Their team of experienced independent consultants provides tailored solutions across the entire product lifecycle, with a strong emphasis on compliance, quality, and client success.
Industries
Nr. of Employees
small (1-50)
NanoClimate
Raleigh, North Carolina, United States, North America
Services
Consulting support for CMC regulatory submissions, responses to agencies, meeting preparation, and ongoing regulatory strategy throughout development and post-approval.
End-to-end manufacturing support for biologics including cell line development, process optimization, scale-up, validation and commercialization oversight.
Support for establishing and maintaining quality management systems, SOPs, training, audits, gap assessments, validation and deviation/change control processes.
Consulting support for CMC regulatory submissions, responses to agencies, meeting preparation, and ongoing regulatory strategy throughout development and post-approval.
End-to-end manufacturing support for biologics including cell line development, process optimization, scale-up, validation and commercialization oversight.
Support for establishing and maintaining quality management systems, SOPs, training, audits, gap assessments, validation and deviation/change control processes.
Expertise Areas
- CMC regulatory strategy and dossier preparation
- Biologics process development and scale-up
- Quality systems design and GxP compliance
- Technology transfer and manufacturing oversight
Key Technologies
- Mammalian cell culture
- Cell line development
- Microbial/bacterial process development
- Process scale-up and optimization