Consultants
Principal and Founder
Ms. Bermejo is the principal consultant and founder of Veraz Biosolutions. Ms. Bermejo has approximately 30 years of professional experience. She has held leadership and management positions in small and large innovative companies in the biotechnology and pharmaceutical fields. Ms. Bermejo has managed multi-million dollar projects and routinely utilizes project management and six sigma principles in taking projects to successful completion. Prior to founding Veraz Biosolutions, Ms. Bermejo was Vice-President of Encova Consulting. She has a chemical engineering graduate degree from Northwestern University. Ms. Bermejo is member of ISPE and PDA organizations.
Types of Projects
While every project is unique and requires a different solution, having tackled similar projects in the past provides a tool kit to select from to customize pragmatic solutions to the challenges of each project and bring it to successful completion.
- Multiple projects for Process Scale-Up and Technology Transfer of biological drug substances from one contract manufacturing organization to another.
- Process Validation of commercial biological process (orphan drug) and CMC write-up.
- Manufacturing oversight for late clinical processes, compliance support for deviations, process troubleshooitng, root cause determination, batch record reviews, validation program reviews.
- Continued process verification for commercial production, manufacturing support from a compliance and process trending perspective.
- Technology feasibility evaluations.
Clients and Past Work Experience
Our personnel have hands-on driven consultancy experience and management experience at innovative companies. We have been on your side of the table and are fully familiar with the responsibilities and challenges that good stewardship requires.
Below you will find a partial list:
Eli Lilly
Akzo Nobel
Jacobs Engineering
Biologics Consulting Group
Dendreon
Biolex Therapeutics
Pfizer