Promotional Materials Review - MLR

The Medical, Legal, and Regulatory (MLR) review process is pivotal in navigating the complex landscape of pharmaceutical and medical devices’ advertising Regulatory laws to ensure successful product launches and effective market entry. At Freyr, we provide industry-leading services covering promotional and non-promotional Regulatory review, medical review, legal review, HA submission support, MLR process consulting, and MLR coordinator support. We aim to make the MLR process hassle-free while driving quality, efficiency, and compliance. Our highly trained, agile teams including physicians, doctorates, and pharmacists proficient in various therapy areas, work together across multiple regions. Our global SMEs provide round-the-clock support through our robust MLR processes.

Services

• MLR REVIEW SERVICES

• MLR PROCESS CONSULTING

• MLR COORDINATOR SERVICES

MLR Review Services

Regulatory review

Regulatory review is a meticulous process performed by our team to ensure compliance and accuracy in promotional and non-promotional material. Our responsibilities include:

• Ensuring Regulatory compliance with country-specific guidelines established by Regulatory authorities such as FDA, EMA, MHRA, TGA, HSA, PMDA, ANVISA, LATAM, and Health Canada.
• Verifying the material's accuracy and completeness of medical and scientific claims.
• Checking for consistency and avoiding exaggeration of content compared to the referenced or source documents.
• Verifying the suitability of content for various types of materials, such as brochures, handouts, A/V ads, and others.
• Evaluating the language and presentation of materials to ensure clarity, accuracy, and non-misleading communication based on the intended audience.
• Verifying alignment of design and background elements with the content to avoid discrepancies (e.g., ensuring images of pediatric populations are not used in contexts where the product is not prescribed for that population).
• Serving as Subject Matter Experts (SMEs) on Regulatory matters during internal meetings, PRC meetings, external presentations, and industry conferences.

Medical Review

A medical review is the review of the promotional and non-promotional material in terms of medical aspects which involves the following:

• Review the drug-related content, including indications, dosage, instructions for use, and mechanism of action, to ensure appropriateness and accuracy as per the Prescribing Information (PI), SmPC, Patient Information Leaflets (PILs), and supported by proper clinical and scientific evidence.
• Evaluate the promotional material's alignment with current treatment guidelines and standards of care within the specific therapeutic area.
• Customizing the review checkpoints to fit the therapeutic areas with guidelines or regulations for promotional activities, such as oncology or rare diseases.
• Ensuring a "fair balance" between the presentation of risks and benefits in the promotional material, accurately reflecting potential drawbacks alongside advantages.
• Claim substantiation is essential to ensure that promotional materials are accurate, credible, and meet the necessary standards.
• Verify that any comparative claims made between the drug and other products are supported by valid and reliable data.
• Ensure that medical terminology and synonyms used in the promotional material are thoughtfully selected to ensure clear communication and understanding.

Legal review

Freyr’s team of legal experts can assist you in ensuring that advertising and promotional materials comply with the local country and region-specific laws and regulations, including advertising standards and intellectual property rights.

• Our experts can help ensure promotional materials are aligned, non-misleading, truthful, and balanced.
• Foster compliance with company policies.
• Advise on the appropriateness of the intended audience for a promotional piece.
• Advise on intellectual property, antikickback, privacy, product/company liability, Federal Trade Commission, and regions specific governing bodies and codes of ethics such as FDA, MHRA, EFPIA, ABPI, MHLW, ANVISA, ANAMED.
• Review materials for legal implications, accuracy of claims, and compliance with industry codes of conduct.
• Collaborate with marketing and Regulatory Affairs to address legal concerns or modifications.
• Ensuring the accurate use of brand and company trademarks and service marks.

Deliverables

• 6000+ assets reviewed per annum
• 18+ types of promotional and non-promotional assets
• 6 Eye quality principle enhanced check for Regulatory compliance
• Customized promotional material review for complex therapeutic areas
• Strategic consultation on promotional material compliance
• Multilingual review and translation support
• HA consultation efficient compliance risk management
• Code compliance EFPIA, ABPI, Mdeon, PAAB, IFPMA, CSP, AMG, AIFA, AEMPS, etc.
• Global and local assets adaptation, process streamlining
• Offer compliance review capabilities to support communication for KOLs, MSL, HCPs, patients, consumers, payers, and other medical affairs and marketing commercialization team stakeholders

 Why Freyr? 

• Reduce overall cycle time for review
• Reduce the number of reviews iterations
• Significant cost savings and improved operational efficiency
• Adaptation to various modes of review systems
• Reduced TAT with expedited reviews to meet deadlines
• Scalable multi-country MLR ecosystem
• ZERO Warning Letters/Notice of Violation
• Proficiency with MLR LCM tools like Veeva, PromoMats, and Pepperflow.

MLR PROCESS CONSULTING

Freyr helps pharmaceutical companies ensure compliance with advertising and promotion regulations through our expert consulting services.

• We support the Promotional Review Committee (PRC) for launching brands (US, EU, Asia, etc.).
• Coordination across cross-functional teams to set up the PRC committee.
• Setting up process SOPs for review of promotional materials based on the PRC committee.
• Our senior advisors evaluate the current scenario, identify the gaps in the process, and provide corrective actions.
• Review system implementation and configuration.
• Experience with all e-review platforms.

We support a broad range of promotional and non-promotional assets. Here are a few final deliverables examples-

• Patient Support Applications

• Important Safety Information

• Pharmaceutical Press Releases

• Conference Handouts

• Patient Brochures and Bulletins

• Learning Modules

• 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

Workflow  

• In the backend of process management systems, Freyr’s MLR consultants communicate with the PRC team or support creating a PRC team.
• Senior experts review the PRC process and find the loopholes.
• We create SOPs based on the future business needs of the brand for PRC review purposes. Then the MLR coordinator oversees the allocation of tasks for the MLR review processes. The coordinator ensures that the content owner or writer submits the materials for review, specifying the requirements such as the supporting documents/references and timelines.
• Upon receipt, the coordinator assigns the materials to the respective medical, Regulatory, and legal reviewers, ensuring adherence to timelines.
• They monitor the progress of each review, following up with reviewers as needed to ensure timely completion.
• Once all reviewers have submitted their evaluations, annotations, and comments, the coordinator verifies the completeness and accuracy of the submissions before proceeding to the next stage.
• This involves cross-referencing the reviewer feedback with the original materials to ensure all aspects have been addressed.
• Finally, the coordinator ensures all the necessary documentation is prepared and submitted to the Regulatory authority for approval.

MLR COORDINATOR AND BRAND PORTAL MANAGEMENT SERVICES

At Freyr, we provide best-in-class MLR coordinator services, focusing on quality, efficiency, and compliance. Freyr coordinators are highly trained in all aspects of content review, based on meeting facilitation and document management. Our services enhance your organizational processes and align with industry best practices.

• Support the PRC committee team with the promotional and advertisement material review process.
• Facilitate the MLR review process with relevant stakeholders.
• Ensures promotional and advertisement material meets submission-ready criteria.
• Route promotional and advertisement material to reviewers in a prioritized and timely manner.
• Documents and track review comments and decisions for material under review.
• Schedule and administer all concept, pre-submission, and live review meetings.
• Create and distribute an agenda of material for review meetings.
• Review material to ensure all revisions are accurately incorporated.
• Brand portal management activities.
• Create and distribute an agenda for PRC review meetings.
• Day-to-day facilitator of the advertisement and promotional material review process in LCM systems like Veeva, Pepperflow, etc.