Experienced Submissions Specialists

Our Capabilities

Triangle Regulatory Publishing is a full-service regulatory operations and regulatory submissions company that provides comprehensive document processing and electronic regulatory submission publishing services. Our clients, referred to as sponsors, trust our regulatory submission capabilities because of our proven record in delivering output excellence across all phases of regulatory documentation, production and submission. Founded on over seventy years of combined industry know-how, we proudly offer our clients/sponsors trust, quality, responsiveness and reliability that goes well-beyond the industry norm. We are one of only a handful of boutique regulatory publishing firms in the United States to average the management of a new drug application (NDA) nearly every year. We believe this is a reflection of our capabilities and the trust we have earned.

Our Committment

Since 2010, Triangle Regulatory Publishing has remained committed to delivering on the promise of excellence in regulatory publishing. With ever-changing publishing requirements and standards that are dictated by national and international regulatory agencies, our submissions publishing and document processing specialists participate in ongoing in-house and 3rd party document management and delivery training, regulatory body compliance review sessions, and processing/publishing cross-training initiatives. In this way, the entire Triangle Regulatory Publishing production and delivery team can offer clients/sponsors the assurance of output excellence through workflow effectiveness that adheres to regulatory standards.

Your Service Partner

In being an end-to-end submission publishing service partner with our clients/sponsors, we understand that as the needs of your business evolve; and as the demands of your industry increase, the nature of our relationship will also evolve. Our service partner promise is simple – do what we say we will and deliver when we say we will. We expect doing and delivering to be a dynamic partnership. We expect submission deadlines to shift and publishing documents to shuffle. We expect delays some weeks and quick-turnarounds other weeks. For all of these instances and others that might come up, as your partner in service, we always work alongside you on every work request to provide the know-how, guidance  and expertise necessary to ensure seamless acceptance of regulatory submissions.

Your Solutions Provider

In the United States, Canada and Europe, Triangle Regulatory Publishing proudly provides clients/sponsors with regulatory operations solutions and support for compounds and biologics ranging from early-stage development through full drug approval. As your full-service solutions provider, you have access to our complete suite of services, including:

  • A U.S. Regulatory Agent + Project Team Lead

- Regulatory Strategy Development (All Phases)

  • Regulatory Liaison & Advisor (Drugs, Biologics & Medical Devices)

  • Electronic Submission Management and Guidance

- Regulatory Submission Preparation + Delivery

  • Submission Document Processing and Quality Control

  • -Submission + Report Publishing

  • Post Marketing Approval Regulatory Support

  • Document Management + Archiving

GET TO KNOW OUR CEO | IRISHA G. JOHNSON

Bringing more than twenty years of U.S. Food and Drug Administration (FDA) experiences to her role as chief executive officer, Irisha G. Johnson is the regulatory affairs certified (RAC) subject matter expert who leads the workflow/output efforts of Triangle Regulatory Publishing’s production and delivery team. Irisha’s impressive regulatory background, which includes the successful submission of hundreds of NDAs, BLAs, aNDAs, INDs, CTAs, and sNDAs with specialization in chemistry manufacturing and controls, stems from capabilities she leveraged in previous regulatory roles with industry leaders like GlaxoSmithKline, Gilead Sciences and Covance Inc.

 

UNDERSTANDING REGULATORY SUBMISSIONS

Regulatory submissions are packages of information and data needed by a regulatory agency or authority to evaluate whether a regulated healthcare (biologic, medical device, etc.) product can progress to clinical testing and whether the product is safe and effective for marketing. Electronic Common Technical Document (eCTD) is a standard format in the submission of regulatory packages of information and data (i.e., drug applications, supplements, and reports) to a healthcare agency or authority. eCTD provides a streamlined and harmonized solution to implement the Common Technical Document (CTD) electronically. The current version, v3. 2.2, is utilized by most global health authorities, including U.S. FDA, EMA, Canada, and Japan. However, eCTD v4.0 is the next major upgrade to this standard.

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