Regulatory Submission Services

Pharma regulatory submission services

Prepare, publish, and manage eCTD and SPL submissions with expert support.

LexisNexis Life Sciences Regulatory Submission Services supports the preparation, review, publishing, submission, and lifecycle management of regulatory files. It includes eCTD support and SPL conversion and submission services, with regulatory consulting available to help manage requirements.

eCTD Publishing

Publish compliant submissions

The Electronic Common Technical Document (eCTD) is a standardized format for submitting regulatory submissions to the FDA and other Health Authorities. LexisNexis Life Sciences facilitates preparation, review, publishing, submission, and lifecycle management to support compliance, accuracy, and timeliness.

SPL Submissions

Streamline SPL submissions

Conversion and submission services help guide manufacturers and distributors of drug and biologic products through the FDA’s eDRL SPL process with guaranteed 100% accuracy. Dedicated eDRL Coordinator Services add coordination support for drug or device data management and FDA submissions.

Regulatory Support

Navigate regulatory requirements

Regulatory Consulting Services provide end-to-end help navigating the complex and ever-changing regulatory landscape so products are compliant with applicable laws and regulations. US Agent services can act as the mandatory domestic representative for foreign establishments and facilitate communication with the FDA.

Submission capabilities

From eCTD publishing to SPL listing support, these services cover the practical steps teams need to prepare, submit, and maintain regulatory files.

eCTD lifecycle management

Experts facilitate eCTD preparation, review, publishing, submission, and lifecycle management for regulatory files. Supports compliance, accuracy, and timeliness for FDA and other Health Authorities.

SPL conversion and submission

Conversion and submission services help guide drug and biologic manufacturers and distributors through the FDA’s eDRL SPL process. Support includes SPL and XML formatting.

eDRL coordinator services

Dedicated eDRL coordination support helps streamline drug or device data management and FDA submissions. LexisNexis Life Sciences serves as an expert advisor during the drug listing process.

SPL-based labeling composition

Create print- and web-ready files directly from SPL by using the Content of Labeling portion of an FDA-accepted SPL Drug Listing file. Outputs can include Package Inserts, Medication Guides, Patient Package Inserts, and product web pages.
Explore SPL labeling services

Explore SPL labeling services

SingleSource data library

SingleSource™ for Drug Products Premium provides white-glove support within a proprietary system that collects, stores, and optionally submits product listing, establishment facility, and labeler company data. This information is maintained in a master submission data library.

Regulatory consulting and US Agent

End-to-end consulting services help companies navigate regulatory requirements and stay compliant with applicable laws and regulations. US Agent services facilitate communication between a foreign establishment and the FDA as the mandatory domestic representative.

Learn about US Agent Services

Data Security, Privacy, and Governance

Security and privacy you can count on

Privacy by design

LexisNexis protects customer data wherever it is stored, sent, or accessed. We apply privacy by design principles at every stage of development to ensure security and compliance are built in from the start. Our advanced encryption and rigorous compliance protect your sensitive information. 

Strict security protocols

LexisNexis systems meet the highest standards for information security. We partner with trusted, enterprise-grade cloud providers, continuously monitor and improve our infrastructure,

Who are Pharma Regulatory Submission Services for?

This service is for organizations that need to submit regulatory information to the FDA and other Health Authorities using eCTD and SPL processes. LexisNexis Life Sciences provides publishing, coordination, and consulting support to help teams manage submissions and regulatory requirements.

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  • Drug manufacturers
  • Biologic manufacturers
  • Distributors
  • Device manufacturers
  • Foreign establishments
  • Regulatory affairs

Frequently asked questions

Regulatory submission services help prepare and submit required regulatory files to Health Authorities such as the FDA. LexisNexis Life Sciences supports standardized formats including eCTD and SPL, along with related submission processes.

The Electronic Common Technical Document (eCTD) is a standardized format for submitting regulatory submissions to the FDA and other Health Authorities. LexisNexis Life Sciences supports eCTD preparation, review, publishing, submission, and lifecycle management.

LexisNexis Life Sciences provides conversion and submission services to guide manufacturers and distributors through the FDA’s eDRL SPL process. Dedicated eDRL Coordinator Services also support drug or device data management and FDA submissions.

LexisNexis Life Sciences can use the Content of Labeling portion of an FDA-accepted SPL Drug Listing file to create print- and web-ready materials. Examples include Package Inserts, Medication Guides, Patient Package Inserts, and product web pages.

SingleSource™ for Drug Products Premium is a proprietary system supported by LexisNexis Life Sciences that collects, stores, and optionally submits product listing, establishment facility, and labeler company data. It keeps this information in a master submission data library.

A US Agent acts as the mandatory domestic representative for a foreign establishment and facilitates communication with the FDA. LexisNexis Life Sciences offers US Agent services as part of its regulatory support.

Talk to a Life Sciences Regulatory Professional Today

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Reed Tech is now LexisNexis Life Sciences Solutions

While the Reed Tech name is being retired, the business has long operated as part of LexisNexis. Customers will continue to work with the same regulatory experts, services, and solutions—now unified within LexisNexis Life Sciences to reflect the broader capabilities and global resources of LexisNexis.