Compliant and ethical advertisements are crucial for any industry to educate consumers and help them leverage optimum utility from the product. In the case of medicinal products made for human use, pharmaceutical companies present promotions of their brands through different advertising mediums. However, laws governing pharmaceutical advertisements are far more complex than traditional advertising practices. Stringent laws, rules, and regulations govern the pharmaceutical advertising landscape to safeguard patient interest. Any kind of off-label/spurious drug product claims is dealt with a penalty. Every country has a distinct legislative framework to safeguard consumer and company rights. Administrative bodies and lawmakers scrutinize the advertising and promotional materials to avoid the creation of any misleading claims.
A right Regulatory partner can support your ambitions while being compliant with promotional material review and validation for medicinal products.
We understand that the ever-changing landscape of advertising laws can be difficult to navigate, which is why we are dedicated to staying up to date on the latest developments in the field. Our team is constantly monitoring new regulations and guidelines, so you can rest assured that your company is always in compliance.
At Freyr, our team of experts has extensive experience across a broad range of services linked to the thorough review of promotional and non-promotional material in compliance with region-specific requirements. They include flexible solutions ranging from Regulatory and medical review in addition to the necessary support for promotional materials submissions. Our innovative approaches in dealing with pharmaceutical advertising and promotional activities have helped numerous companies remain competitive in this complex and dynamic Regulatory environment.
Regulatory and medical review of all types of advertising and promotional materials and their validation at global and local levels.
Medical review requirements for promotional products, which are not limited to:
- Review of scientific content and data
- Validation from source documents
- Language preference for safety and efficacy
- Analysis of facts and claims
Regulatory review requirements for promotional products, which are not limited to:
- Consistency between the information of source documents and promotional product
- Information is readable and understandable to the end user
- An expert team of Regulatory and medical reviewers, including a worldwide network of local partners responsible as required, in line with the local requirements
- Clear and concise market feedback provided on alternative options and risks associated with the promotional materials for decisions to be undertaken for each piece/market
- Submission of materials to Regulatory agencies at national levels as required
Freyr Supports Regulatory and Medical Review Compliance
We manage a wide range of materials according to local market requirements. A broad list of applicable codes of practice (but not limited to) are as below:
- Indication Claim Documents
- CME Material
- Patient Support Applications
- Important Safety Information
- Pharmaceutical Press Releases
- Conference Handouts
- Patient Brochures and Bulletins
- Learning Modules
- Core Visual Aids
- Product Information for Websites (Webpages)
- Advertorials/Banners for Websites
- Extensions of Campaign/Marketing Material
- Ads in the Printed Press (Magazines, Newspapers, Periodical Publications, etc.)
- Presentations of Spokespersons or MedReps (Speaker Decks)
- Sales Training Documents