Pharma Suite of Services

The pharmaceutical industry is built upon life-changing innovation. Global Health Authorities, such as the US FDA and Health Canada, create strict guidelines and mandates to ensure the safety and efficacy of drugs born of these innovations. Here at LexisNexis Reed Tech, we understand the complexities of navigating this landscape. To help our customers succeed, we have created a comprehensive suite of pharmaceutical regulatory services provided by Industry Leaders.

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Why LexisNexis Reed Tech?

As leaders in the drug manufacturing and distribution industry, we serve seven of the top ten providers of pharmaceutical products worldwide. Our customers range from small- to mid-size manufacturers and distributors of pharmaceutical products to the largest global leaders. Our pharma services and solutions offer the means to increase productivity, comply with regulations and make more informed decisions quickly.

Ensuring that your company complies with often complex and dynamic Health Authority regulations is critical to success. Engaging with regulatory advisory services from Reed Tech can free up your team to prioritize other priorities. Let our experts help with drug labeling and listing, eDRL Coordinator Services, eCTD (Electronic Common Technical Documents), US Agent Services and other complex regulatory tasks.

Regulatory Consulting Services

End-to-end services that help companies navigate the complex and ever-changing regulatory landscape, ensuring that their products are safe, effective and compliant with all applicable laws and regulations.

Electronic Common Technical Document (eCTD)

The Electronic Common Technical Document (eCTD) is a standardized format for submitting regulatory submissions to the FDA and other Health Authorities. With decades of eCTD experience, our experts facilitate the preparation, review, publishing, submission and lifecycle management of your files, ensuring compliance, accuracy and timeliness.

Drug Labeling and Listing

Ensure regulatory compliance and remove confusion around SPL and XML formatting. Reed Tech offers conversion and submission services by expert staff to guide manufacturers and distributors of drug and biologic products through the FDA’s eDRL SPL process. Experience matters for assured compliance.

SingleSource™ for Drug Products Premium

White-glove support and guidance within our proprietary system that collects, stores and optionally submits global product listing, establishment facility and labeler company data in our master submission data library.

eDRL Coordinator Services

Streamline drug or device data management and FDA submissions through dedicated eDRL coordination support. We will serve as an expert advisor to help you through the drug listing process.

FDA SPL Composition Process

Gain increased control and create print and web-ready files directly from SPL. With labeling composed in XML, we offer a process to use the Content of Labeling portion of the FDA-accepted SPL Drug Listing file as the source for Manufacturing Package Insert (PI), marketing media-for print or advertising use, Med Guide, Patient Package Insert (PPI) and product web pages.

Drug Label Research and Analytics

Quickly and easily access the entire sets of FDA-approved prescription, over-the-counter (OTC) and homeopathic drug products and EU centralized prescription drug products.

US Agent

US Agent acts as the mandatory domestic representative for the foreign establishment and is responsible for facilitating communication between the foreign establishment and the FDA.

Cosmetics Regulatory Compliance

Determine how your regulatory compliance team will answer specifics around documentation, standard operating procedures, complaints and recalls and product data. Answering these questions will be a major indicator to gauge your strategy for compliance.

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Additional Regulatory Compliance Services

Find answers to your queries about our life sciences products right here.

What is included in a drug listing?

A drug listing submitted to the FDA contains drug product key information, typically including: product information (National Drug Code (NDC, brand name and generic name, dosage form, route of administration and strength and unit of measure of the drug substance), labeling, marketing status and establishment information. Reed Tech can help you collect this information and covert it to the right format for Health Authority submission.

How do I submit to FDA?

The FDA utilizes an electronic system, the Electronic Drug Registration and Listing System (eDRLS), for drug registration and listing via an electronic submission gateway (ESG). As a third-party service provider, Reed Tech is able to make submissions to the ESG on behalf of our customers.

How do manufacturers listings vs. distributors listings differ?

The key difference is in who submits the drug listing and what it represents between manufacturers and distributors. The submitting party may vary based on individual agreements; however, the manufacturer is ultimately responsible for ensuring all their drug products, even those private-labeled by distributors, are listed with the FDA. Additionally, a single drug product might have multiple listings in the FDA database if it is marketed under different brand names by PLDs.

Who can be a US Agent?

The US Agent acts as a crucial liaison between the foreign manufacturer and the FDA, ensuring smooth communication and regulatory compliance. To qualify as a US Agent, a company or organization must be registered and established in the US. They also must have a physical presence, availability during normal business hours to answer questions from the FDA or facilitate communication and be US-based. Reed Tech is an experienced US Agent.

LexisNexis Reed Tech has expanded service offerings to help companies gain peace of mind and form strategies to manage regulatory requirements. Give us a call or email to schedule a complimentary Regulatory Consulting session with the experts at Reed Tech.

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