Case Studies

PROBLEM STATEMENT Client 1 and 2: Two different consulting companies needed a consultant to conduct a retrospective review of major and critical change controls, deviation investigations, and OOS investigations to identify the gaps in investigations and change...

PROBLEM STATEMENT Client 1: A large renowned consulting company needed a principal consultant to perform third-party review and batch certification for one of their global pharma clients, who was working on warning letter remediation for multiple sites. Client 2: A...

PROBLEM STATEMENT Client: A large renowned compliance consulting company needed a principal consultant to develop a multi-site holistic remediation plan for warning letters (WL) remediation. EXPERTISE AND SOLUTIONS The client company hired a principal consultant from...

PROBLEM STATEMENT Client: A renowned large consulting company (client) needed a Principal consultant to get a virtual company ready for Pre-approval inspection (PAI). The virtual company was manufacturing ophthalmic API and Drug products and was getting ready for an...

PROBLEM STATEMENT Client 1: Project 1: A renowned large consulting company needed a consultant to perform FDA 483 Commitment Verifications for one of their Large Global Pharma Clients to ensure that all the FDA commitments were adequately completed, and FDA update...

Problem Statement Client: A law firm was working on litigation issues for vaccine products. The client needed an analytical and Quality expert to conduct a regulatory assessment of product-related issues and provide an assessment report, including a deposition....

Problem Statement Client 1: One of the sites of a large Pharma company producing ophthalmic products (solutions and suspensions) was getting ready for Health Canada Pre-Approval Inspection (PAI) and hired a consulting company to prepare for PAI. Client 2: One of the...

Problem Statement Client: Our client was a large global biopharmaceutical company and was working on different work streams of consent decree remediations. Our client needed someone to lead the remediation effort for the new Quality Control Lab Qualification and work...

Problem Statement Client: An investment company was interested in making an investment decision for a Biopharmaceutical company and needed quality assessment to understand regulatory compliance risks associated with the company’s product portfolio and the several...

Problem Statement Client 1: An early-stage virtual (discovery stage) pharmaceutical company, developing novel small molecule drug candidates needed the Quality unit to support the IND enabling and Phase 1 studies. The company did not have a quality unit in place. All...