Medical Consulting Practice
Cincero Consulting
Contact

Control Strategy

Our common-sense criticality analysis is a science and risk-based approach leading you to identify critical attributes and critical variability. It seamlessly integrates API and drug product. We customize the control strategy on those variables with the most impact. The control strategy refines through development and is the basis of not only your commercial specifications but also your NDA. Everyone who uses it loves it.

CMO Management

Choosing the right CMO is the most important factor to your success. Our compliance maturity assessment goes deeper than simply CMO compliance. We evaluate their human capital both in quality and quantity to ensure your project can overcome the inevitable unforeseen. Each project is unique. We partner to ensure phase appropriate process development, analytical validation and specifications. We help you turn knowledge into executable controls.

Batch Execution

Only batches that are released can support your clinical trial. We understand phase appropriate batch record generation, review and release. We work with the CMO to evaluate, investigate and remediate deviations. More importantly, we know how much investigation is enough for each phase. We help you get to “yes” when it comes to batch release.

About Us

Small pharma in a virtual setting is what I do. I have worked with small pharmaceutical companies for five years and understand the unique challenges you face. I worked in big companies for 20 years and understand big pharma systems and processes do not work for you.

Our science and risk-based approach to quality and compliance ensures you do the right thing rather than everything. You need to focus your spend on those things that matter most. I understand virtual development and manufacturing.

I will guide you through each phase of development and plan for the increasing GMP requirements as your project progresses towards commercialization.

Call today. You will be glad you did.

Contact