Strivecta Pharmaceutical Consulting
Formulation, Analytical and Regulatory consulting
GMP & CMC auditing
Formulation, Analytical and Regulatory consulting
GMP & CMC auditing
After over 20 years in the pharmaceutical industry, we decided to alter direction of consulting. Now, we share our passion by helping others. Our ramp up process is designed to empower your team and outfit them with the tools they need to succeed. Talk to us today about how we can support your GMP audits, CMC review, company due dilligence and put you on a solid track to success.
Our service includes a comprehensive pharmaeutical consulting to help identify gaps and opportunities, a comprehensive report that includes gaps and improvements. We also offer a suite of quality reviews that will help you get there quickly and smoothly. Clarity upfront regarding the cost and time it takes to audit.
That’s how we ensure your success.
Quality consulting in pharmaceutical are key—that’s why when it comes to client selection, we’re choosy. We want to give each of you the time and guidance you deserve. Whether you’re seeking a strategic alliance with the right partner or a special skillset or tool, send us a note today. Together we’ll create and refine your plan for success. We didn’t get there alone. And neither will you.
Reviewing CMC sections, Clinical reports, Validation and Product development for potential buyers of programs or acquisitions of company
Assist selecting and managing CDMO / CRO. On-site auditing of API manufacturer, testing labs or drug manufacturing company.
Before filing your IND, ANDA or NDA it is safer to make sure the CMC section has what is needed.
Optimizing or evaluating drug formulation, formulation patent review or writing, on-site formulation work or overseeing CRO, CDMO or CMO manufacturing, including Clinical supply manufacturing.
Analytical development, verfication and validation recommendations and review.
Pre-clinical activities or early clinical phase protocol reviews, writing and auditing. Regulatory recommenations and consulting.