乐鱼（Leyu）体育官网

Insights

Fresh thinking and actionable insights that address critical issues your organization faces.

Learn more

Resources

Services

乐鱼（Leyu）体育官网's multi-disciplinary approach and deep, practical industry knowledge help clients meet challenges and respond to opportunities.

Services to meet your business goals

Technology Alliances

乐鱼（Leyu）体育官网 has market-leading alliances with many of the world's leading software and services vendors.

View all Alliances

Industries

Helping clients meet their business challenges begins with an in-depth understanding of the industries in which they work. That鈥檚 why 乐鱼（Leyu）体育官网 LLP established its industry-driven structure. In fact, 乐鱼（Leyu）体育官网 LLP was the first of the Big Four firms to organize itself along the same industry lines as clients.

How We Work

We bring together passionate problem-solvers, innovative technologies, and full-service capabilities to create opportunity with every insight.

Learn more

Careers & Culture

What is culture? Culture is how we do things around here. It is the combination of a predominant mindset, actions (both big and small) that we all commit to every day, and the underlying processes, programs and systems supporting how work gets done.

Learn more
Relevant Results
Sorry, there are no results matching your search.
Autocomplete suggestions are available. Use up and down arrows to review and enter to select.
See more results

Supply Chain Security for Life Sciences

Leading global organizations to meet their Serialization, Traceability, and Device Tracking compliance requirements and optimize their business operations.

Serialization & Traceability

We help Rx Manufacturers, Re-packagers, and Distributors meet their compliance requirements and also to implement processes and controls that achieve improvements in quality and reduction in operational and administrative expenses听through pharmaceutical serialization and traceability.

Legislation and regulations such as the U.S. DSCSA and the EU FMD required rapid deployment of technologies and integrations. If not carefully planned, designed, qualified, and implemented, the organization鈥檚 solution landscape can become a disparate collection of software versions, configurations, functionalities, and integrations, contributing to a company鈥檚 overall operating costs and compliance risks.

乐鱼（Leyu）体育官网 is equipped to review your entire Serialization, Traceability, and Reporting solution landscape, or to focus on a specific operational / functional area based on your operating environment, risks, and opportunities.听

Stage 1: Drive Serialization and Product Tracking compliance

1

New / revised manufacturing sites, lines and equipment

2

New / revised products, legislation, and business development / markets

3

New / revised suppliers
(3PL, 3PPs, CMOs)

4

New / revised customers

5

New / revised systems and data

Stage 2: Build Serialization and Product Tracking sustainability

  • Change Control System
  • Labeling & Artwork System
  • Quick Hit Sustainability Mechanisms
  • Regulatory Intelligence
  • Trade Agreements
  • QA Agreements

Device Tracking

We help global device Manufacturers modernize their complaints handling and device tracking processes with enabling technologies scaled to their specific needs, in order to modernize their device tracking platform and improve their overall quality management system.听

Device Tracking regulations such as US FDA 21 CFR Part 821 and Canada Medical Devices Regulations Part 1 Section 66-68 require tracking of certain implanted devices these requirements are intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention.

Our flexible device tracking solution addresses the end-to-end device tracking process by integrating the device tracking, complaints, warranty claims and regulatory reporting processes, within a scalable, low-code, cloud platform.

Customer portal

(for device registration, data verification, Service requests)

Other intake

(email, fax)

Document processing

(doc capture, OCR, batching)

Integration

(Internal & External systems)

Device tracking system

(workflow-based application to maintain data on device location and status)听


Master data
听		Transaction data

听

Collect听dataMaintain dataProvide service

Data migration | Data privacy | Localization

Field Actions Management

(workflow-based application to manage field actions and feedback)

Mailing & letter generation

(templates, mailing groups, tracking mail, responses)

Quality process audit

(audit data & process, quality coaching)

Reporting

(std./ad-hoc reports, dashboards, alerts)

Publications

Dive into our thinking:

U.S. Drug Supply Chain Security Act (DSCSA) compliance assessment

Download PDF

Meet Our Team

Image of Dave Colombo
Dave Colombo
Director, Life Sciences Advisory, 乐鱼（Leyu）体育官网 US
Image of Sarath Ramakrishnan
Sarath Ramakrishnan
Director, Life Sciences Advisory, 乐鱼（Leyu）体育官网 US
Read bio
Image of Rajesh Misra
Rajesh Misra
Principal, Advisory C&O Commercial, 乐鱼（Leyu）体育官网 US
Read bio
Image of Dave Colombo
Dave Colombo
Director, Life Sciences Advisory, 乐鱼（Leyu）体育官网 US
Image of Sarath Ramakrishnan
Sarath Ramakrishnan
Director, Life Sciences Advisory, 乐鱼（Leyu）体育官网 US
Read bio
Image of Rajesh Misra
Rajesh Misra
Principal, Advisory C&O Commercial, 乐鱼（Leyu）体育官网 US
Read bio

Explore other services tailored to your business

Service
EU Medical Device Regulation (MDR) Advisory Services
Read more
Service
Quality Services for Life Sciences
Read more
Service
Regulatory Affairs Services for Life Sciences
Read more

乐鱼（Leyu）体育官网. Make the Difference.


Some or all of the services described herein may not be permissible for 乐鱼（Leyu）体育官网 audit clients and their affiliates or related entities.

The information contained herein is of a general nature and is not intended to address the circumstances of any particular individual or entity. Although we endeavor to provide accurate and timely information, there can be no guarantee that such information is accurate as of the date it is received or that it will continue to be accurate in the future. No one should act upon such information without appropriate professional advice after a thorough examination of the particular situation. 乐鱼（Leyu）体育官网 LLP does not provide legal services.

The information contained herein is not intended to be 鈥渨ritten advice concerning one or more Federal tax matters鈥� subject to the requirements of section 10.37(a)(2) of Treasury Department Circular 230.

漏听2025 乐鱼（Leyu）体育官网 LLP, a Delaware limited liability partnership and a member firm of the 乐鱼（Leyu）体育官网 global organization of independent member firms affiliated with 乐鱼（Leyu）体育官网 International Limited, a private English company limited by guarantee. All rights reserved.

For more detail about the structure of the 乐鱼（Leyu）体育官网 global organization please visit听.

Thank you!

Thank you for contacting 乐鱼（Leyu）体育官网.听We will respond to you as soon as possible.

Contact 乐鱼（Leyu）体育官网

Use this form to submit general inquiries to 乐鱼（Leyu）体育官网. We will respond to you as soon as possible.

By submitting, you agree that 乐鱼（Leyu）体育官网 LLP may process any personal information you provide pursuant to 乐鱼（Leyu）体育官网 LLP\'s .听

An error occurred. Please contact customer support.

Job seekers

Visit our careers section or search our jobs database.

Submit RFP

Use the RFP submission form to detail the services 乐鱼（Leyu）体育官网 can help assist you with.

Office locations

View locations

International hotline

You can confidentially report concerns to the 乐鱼（Leyu）体育官网 International hotline

Press contacts

Do you need to speak with our Press Office? Here's how to get in touch.

Headline