FDA Ad Promo Submission Services

For organizations seeking streamlined FDA Ad Promo Submission Services, the process begins with strict regulatory requirements outlined in 21 CFR 314.81(b)(3)(i) and 21 CFR 601.12(f)(4). Any promotional material distributed after a product’s approval, whether directed at healthcare professionals or patients, must be submitted to the FDA using Form 2253. This step ensures full alignment with OPDP Advertising Regulations, and the process is widely recognized in the industry as "2253 submission."

To navigate these requirements, many pharmaceutical and biotech companies rely on experienced partners for their FDA Ad Promo Submission Services, ensuring every OPDP 2253 Submission delivers accurate, compliant information while supporting timely review.

Expertise in FDA Ad Promo Submission Services

At Freyr, our team specializes in comprehensive FDA Ad Promo Submission Services—supporting clients with everything from collection and validation of all promotional materials (ads, labeling, websites, and more) to electronic Common Technical Document (eCTD) outputs and final FDA dispatch. We provide strategic guidance and tactical support throughout each step, ensuring your OPDP 2253 submissions meet the latest guidelines for pharmaceutical advertising compliance.

Freyr supports:

• Collection of promotional materials such as advertisements, labeling, brochures, websites, social media content, and any other materials intended for public consumption
• Creation of 2253 Forms
• Multilingual (including Spanish) storyboard preparation
• Compilation of binders and clean promotional material versions
• Create eCTD submission output
• Final validation, quality checks before submission, and delivery.

Our experienced Regulatory Affairs Managers and MLR team ensure both HCP and direct-to-consumer ad promo content adheres to all FDA Promotional Review standards.

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 achieve robust Pharmaceutical Advertising Compliance, adherence to metadata requirements is essential for every OPDP 2253 Submission. From applicant information to supplementary metadata elements, our team meticulously compiles all necessary documentation, including the 2253 Form (Module 1.1), Current Product Labeling (Module 1.14.6), and a clean version of promotional material (Module 1.15.2.1.1). This attention to detail streamlines the FDA Promotional Review process and supports strict compliance with evolving OPDP Advertising Regulations.

Efficient Dispatch to FDA

After thorough compilation and verification of all required documents, each 2253 submission is 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 regulatory review for all FDA Ad Promo Submission types.

Archival Process

Our expert team also manages the archival of every ad promo submission, including essential receipts and acknowledgments, for secure internal tracking. This end-to-end approach guarantees traceability, transparency, and sustained compliance with all OPDP 2253 requirements.