FDA Ad Promo Submissions - OPDP 2253

Freyr specializes in executing 2253 Ad Promo Submissions for pharmaceutical companies, offering expertise in Regulatory compliance and strategic guidance. Our team ensures meticulous documentation and efficient dispatch to FDA centers, streamlining the submission process and facilitating accurate and compliant dissemination of pharmaceutical information.

FDA Ad Promo Submissions - OPDP 2253

Regulatory compliance is non-negotiable in the drug approval process for the pharmaceutical and biotech sectors. Under 21 CFR 314.81(b)(3)(i) for drugs and 21 CFR 601.12(f)(4)) for biologics, once a product has been approved, any materials intended for promotional use must be submitted to the FDA at the time they are first distributed. These submissions must include FDA Form 2253, titled "Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use," and are commonly known as "2253 submissions.”

For seamless execution of 2253 Ad Promo Submissions to the FDA, the pharma industry turns to Freyr for its expertise. With years of experience and a proven track record, we are your trusted partner in navigating the complex landscape of ad-promo submissions.

Expertise You Can Trust

At Freyr, our team is highly skilled in handling 2253 Ad Promo Submissions for the USFDA. We have developed expertise in this area through extensive work with clients of all sizes, from large corporations to small businesses. Whether you need help with the submission process or strategic advice on 2253 Ad Promo requirements, Freyr is ready to streamline your workflows, provide cost-effective solutions, and ensure quick turnaround times with our dedicated team.

List of activities Freyr team can support with for Ad promo submissions:

  • Collection of promotional materials such as advertisements, labeling, brochures, websites, social media content, and any other materials intended for public consumption.
  • Creation of binders.
  • Creation of 2253 Forms.
  • Creation of storyboard for Spanish materials.
  • Create eCTD submission output.
  • Final validation, QC, and delivery.

Types of 2253 Submissions

Office of Prescription Drug Promotion (OPDP)- 2253 submissions include promotional materials aimed at both:

  • Healthcare professionals (HCPs)
  • Consumers (patients)

These submissions cover a range of materials, from educational content for physicians to direct-to-consumer advertisements. They are essential for ensuring that accurate and compliant information about drug products is disseminated effectively.

Meticulous Documentation

To ensure thorough submissions, adherence to metadata requirements is essential. From applicant information to additional metadata elements, our team meticulously compiles all necessary documentation, including the 2253 Form (Module 1.1), Current Product Labeling (Module 1.14.6), and Promotional Material Clean Version (Module, facilitating the review process.

Efficient Dispatch to FDA

Upon compilation and verification of required documentation, submissions are dispatched to the appropriate FDA centers—CDER (Center for Drug Evaluation and Research) or CBER (Center for Biologics Evaluation and Research)—ensuring efficient processing and review.

Archival Process

In addition, the Freyr team is competent in processing the archival of the submission, receipts & acknowledgments for internal tracking.

FDA Ad Promo Submissions - OPDP 2253

  • At Freyr, we provide services and solutions to support pharma companies with Regulatory Affairs operations and strategy
  • Provides strategic and tactical support for the submission process globally
  • Submission support for healthcare professionals and consumer-based materials
  • Provide support for core launch materials as well as non-launch materials
  • We extend our submission support to TV and radio advertising for preclearance and launch
  • We provide submission support for re-submission and amendment submissions
  • We also do post-marketing submissions and accelerated approval (mainly for FDA submissions)
FDA Ad Promo Submissions
  • Our submission team understands drafting requirements for submissions
  • Freyr has an experienced team of MLR and Regulatory Affairs Managers, who understand compilation and submission requirements to health authorities
  • Support clients with processing and compiling Advertising and Promotional (Ad Promo) submissions to the OPDP division of the FDA as per the client’s specifications
  • We offer end-to-end submission management and establish business processes for ad promo operations
FDA Ad Promo Submissions

Celebrating Customers Success


Medicinal Products

Promotional review


Our AdPromo review relationship with Freyr is continuing to evolve as we move forward. The team is collaborative and responsive. We are happy to collaborate with you on this important program.

Sr. Manager, Regulatory Affairs – Labeling and AdPromo

UK-based, Multinational Pharmaceutical and Biotechnology Company


Medicinal Products

Conference Support


I wanted to thank you and all the team who have worked on this project around the clock. You and your team exhibited good time management and customer service skills throughout the project by promptly responding to our queries and accommodating multiple iterations of the design and content. all of this has led the project to be delivered within such short deadlines.

Thank you once again and we look forward to working with you again when the opportunity presents itself.

Business Development Team, FDF RoW market

India-based, Multinational Pharmaceutical and Biotechnology Company