LEXISNEXIS LIFE SCIENCES SOLUTIONS

About Us

Confident female doctor working in clinic

Medical Devices, Rx, OTC, and
Biologics Regulatory Professionals

LexisNexis Life Sciences Solutions offers product and service solutions to help Life Sciences professionals gain control over their own and their industry’s data. Our offerings smooth the collection, transformation, submission, and analysis of regulatory data for manufacturers and distributors or medical device and drug products and for those who support them in consulting and IT roles. Our customers range from small to mid-size producers and distributors of pharmaceutical and medical device products to the very largest global leaders.

Medical Devices

Our core business is managing medical device
Unique Device Identification (UDI) product data for global health authorities.

REQUEST DEMO

LEARN MORE

Pharmaceutical & CoSMETICS

We provide outsourced Structured Product Labeling Services (SPL) for US FDA product listings, eCTD, US Agent and other drug listing & establishment registration services.

REQUEST DEMO

LEARN MORE

Leverage Our Expertise in Life Sciences

450+

Global Medical Device clients

33%

Medical Device UDI records electronically submitted to US FDA GUDID

1,000,000+

Medical Device UDI records submitted globally

1,000+

Global Pharmaceutical clients

20+

Years of Pharma SPL service

99.95%

Pharma FDA SPL submissions delivered within contracted time

LexisNexis Life Sciences Solutions Business Credentials

LexisNexis Life Sciences Solutions Project Managers are PMP-certified

The Project Management Professional Certification or PMP is conveyed by the Project Management Institute, and is the worldwide gold standard of project management certification.

LexisNexis Life Sciences Solutions Software Development management and staff members are certified as Agile Scrum Masters (CSM) by the Scrum Alliance

A Certified ScrumMaster® helps project teams properly use Scrum, increasing the likelihood of the project’s overall success. CSMs understand Scrum values, practices, and applications and provide a level of knowledge and expertise above and beyond that of typical project managers. CSMs act as “servant leaders,” helping the rest of the Scrum team work together and learn the Scrum framework. CSMs also protect the team from both internal and external distractions.

HL7 Standards Board Participation

The LexisNexis Life Sciences Solutions team has an employee sitting on the standards setting board of this organization. Health Level Seven International (HL7) is a not-for-profit, ANSI-accredited standards developing organization dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery and evaluation of health services. HL7 is supported by more than 1,600 members from over 50 countries, including 500+ corporate members representing healthcare providers, government stakeholders, payers, pharmaceutical companies, vendors/suppliers, and consulting firms.

LexisNexis Life Sciences Solutions HR Representatives are SHRM CP & SCP-certified

The Society for Human Resource Professionals regards SHRM-CP/SCP (entry/mid-level and senior level) as the global standards in certification for the HR profession.

LexisNexis Life Sciences Solutions Security Team Credentials

ISO/IEC 27001:2013 certification for international information security standard

ISO 27001 is the leading international standard for information security management systems (ISMS) and thus the most important cyber security certification.

Certified Information Systems Security Professional (CISSP)

An independent information security certification governed by the International Information Systems Security Certification Consortium, also known as (ISC) ². CISSP is a globally recognized certification in the field of IT security.

Certified Information Security Manager (CISM)

Certification for information security managers awarded by ISACA (Information Systems Audit and Control Association). The intent of the certification is to provide a common body of knowledge for information security management. The CISM focuses on information risk management as the basis of information security. It also includes material on broader issues such as how to govern information security as well as on practical issues such as developing and managing an information security program and managing incidents.

Certified Ethical Hacker (C|EH)

A qualification obtained from the EC-Council by assessing the security of computer systems, using penetration testing techniques.

CCNA (Routing & Switching, Security, Wireless)

CCNA (Cisco Certified Network Associates) in an IT certification from Cisco specific to Cisco-specific routers and switches, and includes other elements including security and wireless devices.