Strategic Partners

Allo Source

logo-allosourceFounded in 1994, Centennial, Colorado based AlloSource continues to increase the availability of high quality, safe allografts. Showing respectful appreciation for the gift of donation, AlloSource saves and improves lives by maintaining the highest standards in recovery, processing and storage of human tissue and cells, while striving to develop new therapeutic technologies. AlloSource provides service to the country’s most reputable non-profit organ procurement organizations that have direct input and oversight into the company’s business operations. AlloSource is accredited by the American Association of Tissue Banks. It operates three facilities in Centennial, Salt Lake City and Cincinnati and employs over 240 people.

www.allosource.org

Nelson Laboratories

logo-nelson.gifNelson Laboratories provides full, life-cycle microbiology testing services for medical devices, pharmaceuticals, and natural products. Their services help companies mitigate risk, be first to market, and succeed with customers. Since being founded 1985 by Dr. Jerry R. Nelson and Lynda S. Nelson, Nelson Labs has been making a name for itself with rigorous testing standards and an unwavering commitment to its clients. Now, a recognized industry leader, Nelson Labs continues to focus on what brought them to be an industry leader — thought leadership and approachable experts, a customer-centric approach, a real-time project management portal, metric-driven testing processes, and global compliance expertise and support. Nelson Laboratories is currently located in Salt Lake City, Utah.

www.nelsonlabs.com

CPC Clinical Research

CPC_CH_Logo---WEbCPC is an academically led clinical research organization who has responded to the demands of a fast-paced clinical research industry and competitive market for over two decades. CPC offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. These individuals are on the cutting edge of scientific, clinical and regulatory developments. CPC is known for its collaborative approach with sponsors, sites, and vendors providing superior communication and seamless clinical trial management. When CPC infuses scientific leadership and academic credibility into clinical trial services, the results speak for themselves. CPC is located in Aurora, Colorado.

www.cpcmed.org

ReproTech, Ltd.

logo-reprotechReproTech, Ltd. specializes in long-term cryostorage and transportation of reproductive tissues. Now more than ever, IVF centers need to understand how long-term embryo storage can affect their business. That’s embryonomics. That’s the doctrine of dealing with frozen accounts in order to keep your practice profitable and safe today, and more valuable when you decide to sell or retire. If this thought is new to you, let ReproTech show you how embryonomics can protect your center – now and in the future.

ReproTech, Ltd., with three regional facilities, is a one-stop resource specializing in effective solutions to the challenges faced in today’s ever changing field of Reproductive Medicine. Please note that in addition to our routine storage services, ReproTech also provides:

  • Shipping and storage services for specimens which potentially contain an infectious disease, including HIV.
  • Embryo donation assistance following FDA regulations and AATB standards.
  • The nation’s Largest Fertility Preservation Network, which helps IVF Centers to provide Fertility Preservation services with marketing assistance and storage services provided by ReproTech.

ReproTech is available to help you implement an FDA compliant storage protocol that is easy to follow and secure. Then when necessary, ReproTech coordinates the safe and efficient shipping of specimens to one of our regional cryostorage facilities.

ReproTech, Ltd.
The Cryostorage and Compliance Experts
Coconut Creek, Florida 888.953.9669
St. Paul, Minnesota 888.489.8944
Reno, Nevada 888.831.2765
www.reprotech.com

D2Xchange

d2xchangeD2Xchange provides digital document imaging, scanning software and content management software to clients across the country with an emphasis on healthcare, behavioral health, biotechnology and manufacturing. With more than 15 years of industry experience, D2Xchange offers a full continuum of paperless office solutions to help organizations manage data and documents securely and cost-effectively.

D2Xchange manages a scanning bureau in Denver to assist organizations interested in outsourcing document conversion projects. The company also offers hosted and on-premise document scanning and electronic content management systems. D2Xchange is bonded and maintains errors and omissions insurance. The company has successfully completed consecutive SAS 70 Type II audits to test the physical and technology based security measure the company employs to safeguard its customers’ confidential data.

www.d2xchange.com

Cericon

logo-cericonCericon’s Expertise and Services:

QUALITY SYSTEMS: Improve your quality system and compliance to FDA regulations.

  • Strengthen QSR and ISO based Quality Systems
  • Conduct audits and gap assessment
  • Develop strong, compliant systems in Design Control, Process Controls including Process Validation, Corrective and Preventive Action including Control of Nonconformities, Management Review, Complaint Management, Continuous Improvement, Document Controls, Acceptance, Records, Data Analysis and Reporting

REGULATORY AFFAIRS: Improve your regulatory affairs activities, linking these to business goals.

  • CLEAR warning letters
  • Develop effective FDA 483 responses
  • Develop and complete Corrective Action Plans following FDA Audits
  • Manage recalls, Safety Alerts, & Field Corrections
  • Make compliant MDR decisions

MANAGEMENT: Develop effective leaders and management.

  • Structure successful business and management processes including Management Review, Quality and Strategic Planning, Teamwork Development, Crisis Management, Project Management, Trending, Data Analysis and Reporting

www.cericon.com

Markets

Medical Device Medical Device Navigating the regulatory maze that surrounds the medical de... More detail
Tissue Tissue In May of 2005, the FDA began enforcing a comprehensive set... More detail
Reproductive Tissue Reproductive Tissue In May of 2005, the FDA began enforcing a comprehensive set... More detail
Cord Blood Cord Blood Even to experienced companies, Cord Blood Regulation and Gui... More detail

Consulting Services

Quality System Assessment Setting up and maintaining an effective quality system is essential in order to ensure that products are safe and effective for their intended use. ... More detail
Compliance Remediation If any inspection results in a compliance action from the FDA, or requires corrective action, our experience in compliance remediation can help you ... More detail
Submissions When it is time to get your product to market, there are a number of options available. We work closely with clients to develop a submission strate... More detail
Quality System Development The foundation of any successful organization is a system that ensures consistency, quality and repeatability. Reglera understands that all busines... More detail

Our Services

Consulting Reglera LLC was formed in November 2002 as a Consulting and Outsourcing services provider to the Medical Device Industry after operating since incep... More detail
Outsourcing Regulatory expertise is an absolute necessity in the biomedical marketplace. The medical technology industries can no longer afford a layered system... More detail
Donor Eligibility Outsourcing Donor eligibility determination has historically been one of the areas in the tissue industry to receive the most scrutiny by the FDA. There is a ... More detail
About Strategic Partners