Do you need assistance with your CMC processes?
Our team can help you reach your next milestone
Chemistry, Manufacturing and Controls (CMC)
Leading your manufacturing development from discovery to Submission
Chemistry, Manufacturing and Controls (CMC)
Leading your manufacturing development from discovery to Submission
We can support your product development from early discovery until submission
Our highly skilled consultants offer CMC services which cover strategy development, project management, analytical development, formulation development, CMO selection, audit, and writing/reviewing Module 3. We have experience within both small molecules and biologics and cover a large variety of formulations.
We can support your product development from early discovery until submission
Our highly skilled consultants offer CMC services which cover strategy development, project management, analytical development, formulation development, CMO selection, audit, and writing/reviewing Module 3. We have experience within both small molecules and biologics and cover a large variety of formulations.
Our Chemistry, Manufacturing, and Controls services include:
Analytical Lab
- Method development
- Method validation
- Method evaluation
- Stability studies
- Equipment qualification
- Tech transfer
- Lab Manager
- QC support during Phases I to III
- Release testing
- APV
Production
- Quality Target Product Profile (QTPP)
- Formulation development
- Setting specifications
- Tech transfer
- Equipment qualification
- Upscaling
- Process validation
- Audits
- Vendors and CMO
- Assisting Inspections
- Internal audits
Audits
- Inter audits
- Vendor audits
- Mock Inspections
- Inspection Support
CRO/CMO management
- Identifying
- Management
Quality systems
- GMP systems
- Non-GMP systems
- Design
- Optimizing
- GMP Training
QA Tasks
- Qualified Person
- Release of Clinical Trial materials
- Quality agreements
- Risk assessment
- Deviations
- Change control
- Assisting during Inspections
Module 3 documents
- Writing
- Review
… and more!
Each of our consultants has over 10 years' experience and a vast array of CMC expertise
Our experienced, self driven consultants can provide both strategic leadership and hands-on work to get you to market. This expertise enables Pharma IT consultants to make an impact with minimal training and introduction.
Torben Elhauge
Director of CMC
Utilize functional support from other Pharma IT teams
Pharma IT is a one-stop shop for the pharma, biotech, and medical device industries. Along with our extensive CMC offerings, you can also take advantage of our pharma-focused IT offerings including IT Audit, IT Validation, and the Pharma IT Cloud EDMS+QMS. Further, our Manufacturing team can assist once your product reaches the market.
Each of our consultants has over 10 years' experience and a vast array of CMC expertise
Our experienced, self driven consultants can provide both strategic leadership and hands-on work to get you to market. This expertise enables Pharma IT consultants to make an impact with minimal training and introduction.
Torben Elhauge
Director of CMC
Utilize functional support from other Pharma IT teams
Pharma IT is a one-stop shop for the pharma, biotech, and medical device industries. Along with our extensive CMC offerings, you can also take advantage of our pharma-focused IT offerings including QMS systems, IT Audit, IT Validation, and the Pharma IT Cloud EDMS. Further, our Manufacturing team can assist once your product reaches the market.
Do you need assistance with your CMC processes?
Our team can help you reach your next milestone