Services customized to fit your project needs

Project Management

Our project managers have decades of leadership experience in all aspects of drug development and can effectively move projects from conception to completion.  We apply a structured methodology centered around strategic planning and knowledgeable foresight to minimized surprise setbacks.  Your success is our success, so we will work collaboratively with your team leaders to ensure that all work we perform meets your expectations.

Quality & Compliance

If you need a set of critical eyes with an unbiased perspective, we can provide you with an array of auditing services for investigations, compliance cGMP review, quality systems review, or support for internal audits.  We can also perform audits for your suppliers, CRP and CDMPs, or mock PAIs.  Our team has years of experience working with FDA auditors and up-to-date knowledge of the lates regulatory requirements needed to help you overcome your challenges.

As your portfolio grows, so does the need for assistance with annual product review.  Our consultants are available to provide reports for all your APQR/APR/PQR needs in compliance with 21CFR 211.180(e).

Analytical Services 

From QC Chemists to R&D Principal Scientists a team of experienced analytical professionals are available to meet your laboratory needs.  With ever changing compliance standards, the need for analytical remediation assistance will arise.  If you need a team to quickly bring your product line up to date with the latest cGMP requirements, we have the perfect team for you.  We can perform a thorough gap analysis, provide you with a comprehensive report, and timely execution; see our testimonials page to read highlights from some of our biggest projects.