FDA Compliance Services

Quality System Remediation

The Premier FDA Solutions Difference: Identifying issues. Executing a plan. Preventing recurrence. In this highly regulated industry, managing the everyday manufacturing process can be difficult enough, and companies may not have the resources to properly address quality management system (QMS) issues. We have a large network of quality and compliance experts with the knowledge and experience to identify the root cause of those issues and develop a plan to remediate them – and keep them from recurring.

Remediation Services with Scalable Flexibility

Whether you need one consultant to assist with determining the best approach, or several to work with your team on executing a remediation plan, we can tailor the solution to fit the unique needs of your project.

Proactive Quality System Management

Surviving an inspection is all about managing risk – and knowing what is important to the FDA. What’s important to the FDA is a solid quality management system and documentation, and our quality and compliance experts can help you proactively develop and implement a quality management system that will withstand the closest scrutiny.

The Premier FDA Solutions Difference: We understand that FDA regulatory compliance is but one component of the complex set of regulations impacting Compliance Services for Life Sciences business. Here are some of the key components of our approach to FDA Compliance Services:

• We’ve made the life sciences our sole focus – because the life sciences are incredible.
• We offer flexible staffing solutions so you get the expertise you need when you need it – because compliance is not one-size-fits-all.
• We’re always curating our network of regulatory and quality experts – because integrity matters.
• We advise clients on the design and implementation of compliance programs that address fraud and abuse, labeling and promotion, and various reporting obligations.
• We guide and assist clients through complex internal investigations as well as responding to government enforcement actions related to life sciences regulations, including compliance with the anti-kickback statute, transparency reporting, clinical trial compliance, and privacy.
• We find contract resources for projects for “Right-Sized” Outsourced Staffing and Staff Augmentation & Recruitment (see below).

Engagement Options

Staff Augmentation & Recruitment

It’s difficult to find the right person for your role, especially in today’s challenging hiring environment. Here’s what we do to help with Staff Augmentation & Recruitment:

• Take advantage of traditional outsourced staffing support for a specified duration with work performed on-site, remote, or a mix of both.
• Scale your team quickly by tapping into our extensive network of FDA experts with both FDA and industry quality/compliance work experience.
• We supply scalable flexibility with resources that can quickly adapt to new responsibilities in a changing environment, such as company-critical remediation projects.

Functional Outsourcing

• We provide you with an FTC (Full-Time Consultant) with the specific FDA experience you require for your task and who serves as an extension of your team, maximizing cost savings, flexibility and scalability.
• Our subject matter experts can follow your direction and use your systems, SOPs, and processes, and also serve like an internal resource that can be reallocated when priorities shift. By outsourcing individual functional tasks, you gain more freedom and are able to retain more control of your overall project.

Managed Services/Project-Based Support

• We engage in proactive outsourcing with a right-sized team of FDA industry experts who can manage a project from start to completion.
• Our managers can also work closely with your team to get your project delivered on time and on budget.

FDA Compliance Services for Life Sciences

• Our sole focus is quality and regulatory compliance for the life sciences.
• We leverage our extensive network of FDA, quality, and regulatory experts to provide the right compliance expertise at the right time.
• Whether your need is one consultant for a day or several for a long-term project, we provide scalable staffing solutions that help you build and maintain a great quality system.
• Greatly reduce or eliminate the risk of non-compliance and the related costs and other business impacts
• Improve reliability and efficiency of processes throughout their life cycle
• Increase availability and production throughput for manufacturing facilities

FDA Expert Witness Services

The Premier FDA Solutions Difference: We know the importance of finding the FDA expert witness that meets the specific needs of your case. Whether you are looking for a former FDA official, a Subject Matter Expert, a respected Life Science industry veteran, or someone with experience in some or all of these areas, we can help. Tap into our network of seasoned FDA expert witness professionals and consultants. We take the time to research the best FDA expert witness for your case, whether one expert or many, whether early-stage guidance or expert reports and testimony. Premier FDA Solution understands the urgency that is often required.

Our vast network of FDA expert witnesses can help in areas such as:

• Case Validation
• Document Review
• Written Expert Report
• Early-stage guidance
• Case Review
• Depositions
• Engage in research and support for the litigation team
• Expert Witness Testimony
• Trial Appearances
• Hatch-Waxman Act (ANDAs) and BPCIA (Biosimilars) Cases
• Patent Infringement and Invalidity Analysis