Quality & Regulatory Compliance

With an unmatched combination of experience, rapid response, and world-class expertise, we provide end-to-end expert regulatory, quality, and compliance across all phases and therapeutic areas. We offer you the flexibility to choose your support from full outsourced FSP to discrete solutions and expertise according to your project needs and budget. 

Eliassen Clinical Solutions helps clients deliver products in compliance with relevant regulations.

Providing scalable FSP support, configured to your specific requirements, we are committed to providing the right resources at the right time with an uncompromising commitment to quality and compliance. We have the agility and network to support individual business critical tasks, clinical trial advisory, or provide expert support for remediation and approval. 

Our Core Competencies

Our Core Competencies within Quality & Regulatory Compliance include:

Supplier Quality Assessments, Relationship Management & Remediation Post Market Surveillance
Site & Documentation Audits, GMP/GCP/GLP Auditing
Quality and Complaint Systems, Development & Management, Compliance Engineer
Global Drug & Device Submissions and Approvals: IND, A/NDA, BLA, CBE, DMF Amendment, MHRA, EMA, IDE, 510(k), PMA, CE Marking
483 Responses, Warning Letter, and Consent Decree Prevention & Remediation, Pre-Post Market Approvals
New Manufacturing Site Documentations and Submissions, End-to-End Compliance capabilities
Remediation Design History Files, Device Master Records, Drug Master Files, Risk Management, CAPA, and AE Document Control
Licensing, Packaging, And Labeling Approvals, Global Filings, Country/Product Registrations

Benefits of an Eliassen FSP Partnership 

Building on over 20 years of FSP experience, we offer quality resources and a white-glove client service, based on the guiding principles of partnership, individual attention and trust. We will work with you and your teams to find the best solution and will stay close to your objectives, anticipating your needs as your pipelines and focuses grow and change. 

Cost Efficiencies

Cost Efficiencies

We offer multi-year pricing models, providing predictable budgeting in line with forecasts
Tailored Delivery Model

Tailored Delivery Model

A collaborative approach used to establish and execute optimal practices such as line management, including turnover and training, is managed by the FSP, ensuring stability and leaving you free to focus on other priorities.
Dedicated Resources

Dedicated Resources

Work with fully dedicated resources, managed by you. This means your core in-house team is free to focus on their roles, improving productivity, quality and reducing pressure.
Reduced Timelines

Reduced Timelines

We provide seasoned expert resources with a solution-focused mindset and unrivalled expertise to provide geographic coverage where it may not already exist, maximize efficiencies, and reduce timelines. 
Ability to Plan for Resourcing Needs

Ability to Plan for Resourcing Needs

We provide experience-driven, adaptable resourcing, allowing for rapid resource scaling driven by total flexibility. 
Utilize Your SOPs

Utilize Your SOPs

An FSP model results in reduction in risk and duplicate efforts by leveraging client systems and SOPs. 

Deep Functional Expertise

Deep Functional Expertise

Our focus is exclusively on attracting and retaining world-class talent and delivering best-in-class FSP solutions that fit clients' unique needs through our deep functional expertise. 

Increased Quality & Control

Increased Quality & Control

FSP provides you control over the extent of your outsourcing, allowing you to maintain oversight, better manage studies and ensure quality.