See how The FDA Group partnered with a virtual pharmaceutical startup to establish a robust QMS under challenging conditions. Operating without a traditional infrastructure, this organization faced the monumental task of managing a life-saving drug with strict timing requirements, overseeing a foreign CMO, and maintaining compliance while scaling operations.
Discover how we helped a mid-sized pharmaceutical company develop and maintain its quality department through strategic staff augmentation. We deployed full-time consultants to implement quality systems, manage fluctuating workloads, and provide specialized expertise across multiple subsidiaries. We continue to ongoing support in quality management and clinical operations.
PreparationSubmission-Cover.webp?width=300&name=fda-CaseStudy-Guiding510(k)PreparationSubmission-Cover.webp)
Learn how The FDA Group supported a European biomedical sensor company’s
FDA premarket notification via the 510(k) pathway by redirecting its regulatory strategy to the optimal market clearance pathway, providing expert guidance to a small in-house regulatory team, and engaging with regulators.
Learn how The FDA Group partnered with a multinational pharmaceutical company to support its QMS remediation efforts. This project principally included deviation and CAPA backlog activities, significant corrective and preventive remediation throughout the quality system, and extended support to assist in staff onboarding, training, and maintaining the continuity of improvements made across the QMS. The FDA Group accomplished its goal of eliminating all backlogs on time and under budget.
Learn how The FDA Group partnered with a large clinical service company to manage its QMS remediation efforts and fulfill long-term staffing assignments for two vital roles in the management of the company’s quality and pharmacovigilance functions. This case study demonstrates the value of our convenient, cost-effective workforce model that circumvents the administrative costs and burdens of traditional hiring.
Learn how The FDA Group partnered with a large healthcare product Company to support a Pre-Approval Inspection (PAI) audit preparation project and subsequent quality system remediation efforts at a site within the European Union (EU).
Learn how The FDA Group partnered with a healthcare product Company to support a series of international Quality Audits to assess both Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) throughout the United States, Europe, Asia, and the Middle East.
Learn how The FDA Group supported a series of Risk Evaluation and Mitigation Strategy (REMS) Audits conducted in clinical inpatient pharmacies throughout the United States to evaluate product distribution processes for high-risk healthcare products and ensure those processes were being properly followed and data was effectively communicated to regulators.
Learn how The FDA Group planned and executed a comprehensive remediation project in response to Warning Letters issued to a large healthcare Company, integrating improvements into the Company’s Standard Operating Procedures while training staff in accordance with FDA expectations and monitoring the effectiveness of those improvements over time.
Learn how The FDA Group supported a large healthcare Company’s Quality & Regulatory Audit Project, uncovering significant quality issues and utilizing its staff of former FDA personnel to conduct specialized audits pertaining to Warning Letters and other high profile situations while empowering the Company to improve internal auditing procedures, quality system management, and record review processes.
Learn how The FDA Group has been working closely with a large healthcare Company to overcome a variety of compliance-related issues through comprehensive remediation, quality systems audits, extensive record review, ongoing CAPA improvements, new complaint handling protocols and updated Standard Operating Procedures.