AD promo submission services - Overview
Adherence to medical promotional materials being ethical and as per regulatory standards is paramount across all industries. These materials serve to educate consumers and Health Care Professionals and maximize the benefits of products. In human medicinal products, pharmaceutical companies employ various advertising channels to promote their brands. However, navigating the Submissions of these materials is considerably more intricate than conventional advertising procedures. Many strict laws and regulations govern pharmaceutical advertising to uphold patient welfare.
Selecting the appropriate regulatory partner is essential for achieving compliant promotional material publishing and submission that aligns with laws governing pharmaceutical advertising and promotional materials for medicinal products.
At Freyr, our team of experts has extensive experience across a broad range of services linked to the thorough review of Ad Promo Submissions, promotional materials, and non-promotional material in compliance with region-specific requirements.
Our services include but are not limited to:
Creation of Form FDA 2253
Navigating the complexities of Form FDA 2253, the Transmittal of Advertisements, and Promotional Labeling for Drugs and Biologics for Human Use is a crucial step in the submission process. Our team specializes in the creation of Form FDA 2253, ensuring that all necessary information is accurately captured and presented. We stay up-to-date with the latest FDA guidance to provide you with the most current and compliant forms for your submissions.
Creation of Binders
Organization is key when it comes to regulatory submissions. Freyr's services include the creation of binders that compile all your promotional materials in a structured and accessible manner. This not only streamlines the review process but also facilitates quick reference and retrieval of documents when needed.
Collection of Materials Required for Submission
Our comprehensive collection service includes gathering all types of promotional materials required for submission. Whether it's videos, storyboards in Spanish language, or PDF documents, we ensure that every piece of your promotional campaign is accounted for and ready for submission. Our multilingual capabilities mean that language barriers won't slow down your submission process.
Promotional Material Submissions for Professional/Consumer
Freyr recognizes the distinct differences between professional and consumer-directed promotional materials. We handle submissions for both audiences, ensuring that each set of materials is tailored to meet the specific regulatory requirements and expectations of its intended audience.
Quick Turnaround Time
In the fast-paced world of pharmaceutical and biologic marketing, timing is everything. Experience swift turnaround times without compromising quality, allowing you to stay ahead in the competitive regulatory landscape.
Ad Promo Publishing Challenges
Managing the complexities of Ad Promo publishing presents several challenges:
- Unique Metadata Management: The metadata for these submissions is distinct from regular eCTD submissions, requiring specialized handling.
- Material Type Alignment: Ensuring proper alignment of material types within the submission to meet regulatory standards.
- Document Placement: Accurately adding documents to the relevant sections of the CTD (Common Technical Document).
- Latest Prescribing Information (PI): Including the most up-to-date Prescribing Information (PI) with each submission as mandated by regulations.
Our publishing team is adept at understanding these complexities and ensures that all submissions are completed within the specified timelines, achieving 100% compliance with FDA requirements.
AD promo submission services
Our team brings exceptional expertise to every project, characterized by:
- A dedicated team of 10+ publishers, each with an average of 8+ years of experience in regulatory submissions.
- Proficiency in distinguishing between consumer and professional materials, ensuring submissions are accurately tailored and delivered to the appropriate audience.
- Quick Turnaround Time (TAT)
- Capability to manage expedited submissions with a reduced turnaround time, guaranteeing timely delivery even under tight deadlines.
- Flexibility to rapidly upscale resources to handle high volumes of submissions without compromising quality.
- 100% FDA Acceptance: A proven track record of achieving 100% acceptance by the FDA, underscoring our commitment to excellence and compliance.
Partnering with Freyr for your Ad Promo publishing needs offers significant advantages:
- Efficient processes and expert handling result in significant cost savings.
- Our quick TAT ensures that your submissions are processed promptly.
- Our expertise ensures a 100% acceptance rate by the FDA.
- Ability to handle last-minute submissions without compromising on quality.
- A round-the-clock team is available to provide support whenever needed.
