LET EVERSANA HELP YOU WITH YOUR TISSUECOMPLIANCE NEEDS
Whether it’s short-term assistance or a long-term relationship, our consulting experts andoutsourced services team members can help you with your compliance needs. As your trusted
regulatory partner, we not only advise, but also specialize in implementation and results.

REGULATORY EXPERTISE AND
OPERATIONAL KNOWLEDGE

HIGH LEVEL OF REGULATORYCOMPLIANCE

Staffed with seasoned quality and regulatory staff,
including former FDA investigators, our combinationof regulatory expertise and operational knowledge
helps to ensure your compliance and operational
efficiency. So, whether you have a one-time questionor need ongoing support, EVERSANA’s industry
experts will provide you with the advice you need,when you need it.

Our Outsourcing Compliance Services have been
designed to help tissue, medical device and pharma
establishments comply with the various regulatory
requirements that impact business operations. These
services are developed and implemented to provide
a high level of regulatory compliance while allowing
your business to operate more compliantly andefficiently.

SERVICES INCLUDE:•		Document Control(electronic system)•
Adverse Event and Deviation		Reporting•		Training Management(electronic system)•
				Donor Eligibility System(facilitates electronic donoreligibility determination)•

Complaint Handling•

Recall Management•

Contract Manufacturing Services•

IND/BLA/510(k) Submissions•

Validation and Test Planning•Standard Operating Procedures•Internal Audits•

Supplier Quality Audits•

Executive Management Support•

Regulatory Product Assessment•
FDA and ISO Remediation 				Assistance•Pre-licensure Inspections•
Strategic Route-to-Market 				Planning

To learn more about EVERSANA’s Outsourced Compliance Solutions, call 303.832.8200 or email des@eversana.com© Copyright 2019 EVERSANA | EVERSANA.COM

REGULATORY EXPERIENCE MATTERSImagine This:A small group of research scientists developed a novel HCT/P using cancellous bone. Theysought outside Quality Management System (QMS) and Regulatory expertise to bring thisproduct to market while managing costs. Their challenges included:•		Objective to keep direct headcount and infrastructure to a minimum while having
access to best practice systems, processes and people on an “as needed” basis•

Regulatory pathway for tissue product lacked a clear path to approval•Time and investment was over the provided budget•

Inexperience in regulated industry; preferring to focus their time on the science•

Lack of experience with a QMS and writing SOPs

The Solution••
		Developed and executed a regulatory strategy
Deployed a full suite of outsourcing products to provide QA processes and 		infrastructure ensuring compliance with minimum financial investment•

Prepared the entire QMS•

Provided training and support for client’s FDA inspections

Resulting In:•

Simplified FDA regulatory pathway for the tissue product•

Minimized cost, infrastructure, headcount, and time to market•
		Increased confidence in QMS, since it was developed by experienced
regulatory professionals

Our experts have helped many HCT/P establishments navigate unusual situations, diverse demographics
and unique circumstances to maintain compliance and determine eligibility appropriately.

About EVERSANA™
EVERSANA is the leading independent provider of global services to the life science industry. The company’s integrated
solutions are rooted in the patient experience and span all stages of the product lifecycle to deliver long-term, sustainablevalue for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including
innovative start-ups and established pharmaceutical companies to advance life science solutions for a healthier world. To
learn more about EVERSANA, visit EVERSANA.COM or connect through LinkedIn and Twitter.