Monsef Consulting
Method Development
- Guide you through the method development process for new drug substance and drug products
- Optimize methods for Quality Control purposes through practical method assessments
- Prepare appropriate documents associated with method development
- Test method SOP’s, Method development reports
Method transfer and CMO’s
- Method transfer and CMO’s
- Manage method transfers internally or to CMO’s
- Design feasibility studies and design transfer protocols
- Project manage transfers and help troubleshoot any transfer issues that arise
- Write/review final transfer report
Method Qualification and Validation
- Manage qualification and validation projects for drug substance and drug products
- Develop method qualification and validation protocols per ICH guidelines
- Review data package for method qualification and validation execution
- Write or review report for final data, determining if data shows any need for SOP updates to System Suitability and Acceptance Criteria
Quality Control
- Design lab system to meet GMP guidelines
- Develop SOP’s to put in place the proper controls
- Help develop lab space to meet GMP guidelines
- Data Trending for methods in use for manufacturing
- Use data trending to set proper specifications and controls for late stage and commercial manufacturing
- Stability Programs
- Develop stability programs and write protocols
- Review stability time point data and write stability reports
- Help draw conclusions for drug substance and drug product expiry
Training
- Training programs can be developed specifically for your company needs
- GMP and compliance training
- Lab systems
- Method Development
- Method qualification and validation
- Specific Instrument training
- Class room or lab setting
Courses
Upcoming Courses
On Demand Courses
Recent Articles
Data Integrity: A new FDA draft Guidance
I want to speak to the heart of the matter of data integrity, because I think that it will be of help to folks when setting up related systems or attempting to improve them. The purpose of data integrity controls is to make sure that each assay or procedure can...
Why a Consultant?
In the Pharmaceutical industry, consultants can be very useful in many areas. They can be used for auditing, implementing new technologies, training, or even setting up new systems and software. However, the extent of consultant work can reach far beyond those...
Ultra-Performance Liquid Chromatography
There has been a lot of chatter over the last few years about Ultra Performance Liquid Chromatography (UPLC) instruments. Whenever new technologies come out, two things usually happen: The analytical development groups are instantly writing up purchase orders and...