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CONSULTING SERVICES

Cutting Edge Consulting Tailored for You

We are small firm made up of seasoned consultants experienced in quality engineering and assurance. Our team includes qualified professionals that possess multiple years of hands-on biopharmaceutical industry experience. We work well with multi-site companies and ensure that we have direct line of communication between various teams/sites to ensure that project timelines are met.
We have consultants that have worked in various companies for multiple types of positions and projects. We have worked in companies in various stages in the production process (clinical and commercial) and have worked with the FDA and assisted in regulatory inspections. We have experience working at and with multiple companies including working at Genentech, Novartis, Allergan, Novo Nordisk, Amgen and more.

QUALITY GUIDANCE

Expert Guidance Every Step of the Way. Up to date with industry standards and experience with GMP, GLP, FDA guidance

PROJECT MANAGEMENT

On schedule, excellent communication. Experience with multiple projects in various phases of the pipeline.

ENGINEERING &

PROCESS DESIGN

High qualified consultants with advanced degrees and experience in the biopharmaceutical industry

AUDIT SUPPORT

Support from our experts to prepare for inspections from regulatory agencies.   Internal and external audit preparation.

DOCUMENTATION SUPPORT AND TRAINING

We provide documentation support and training.  Have experience in multiple quality management systems, tracking software, and metrics.

DEVICE DEVELOPMENT AND COLD CHAIN

Our consultants have a strong background in manufacturing of drug substance and drug product, filling, packaging, and drug delivery

Interested in getting advice from an experienced and professional Engineering Consultant? Call ustoday and see what I can do for you.

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