Advertisement and Promotional Material Review Services

Your Partner for Global Medical and Regulatory Compliance Ad Promo Materials

Services We Offer

Why Artixio For Your Ad Promo Review Services?

With a seasoned team of medical, regulatory, marketing and legal experts based in key global markets across North America, Europe, Latam and Asia Pacific, Artixio offers seamless, flexible services to meet your Ad Promo compliance needs.

Ad Promo Review Services Highlights

Subject matter expertise on regulations and requirements governing prescription drug promotion and related communication
Regulatory representation on relevant programs and other cross-functional team
Collaboration with Medical, Legal and Commercial, provides regulatory leadership
Assess the regulatory context and provides regulatory, guidance and/or including requirements related to submission of material to regulatory authorities
Guidance for development products including assessment of potential labeling claims and serving on the labeling working group
Regulatory Intelligence to Monitor and interpret advertising and promotion regulatory landscape, assesses and report impact

Our Services

Medical Review

Participation in Promotional Material Review Committee (PRC) / Legal Medical Regulatory (LMR) Participation
Ensuring consistency of Promotional and Education Material with SmPC
Reviewing and certifying (i.e. signing off), whether electronic or paper
Evidence based evaluation of promotional matetirial
Claims evaluation for accuracy and validity supported by data
Evaluate Relevance to User / Audience

Regulatory Review

Authoring and Review of Submissions to Office of Prescription Drug Promotion (OPDP) or Advertising and Promotional Labeling Branch (APLB)
AuthoringEnsuring compliance with Regulatory Guidelines
Ensure Approved Scope of Use
Ensures claims are consistent with product labeling
Fairness in Comparative Advertising with Competitors
Aggregate report scheduling
Prohibition of Defamation and Exaggerated Advertising
Banned testimony
Ensures materials are fair and balanced, contain appropriate disclaimers, and are not false or misleading
Support with writing and editing standard operating procedures (SOPs).

Non Medical Review

Promotional and Educational Material Review against SmPC / PIL or other local approved product information
Review content, style, accuracy and tone of material
Checking compliance with any applicable codes of practice and appropriate -legislation in the country in scope
FDA Form 2253 Preparation and Submission
Regulatory Intelligence
Regulatory Information Management

Access Global Markets with Reduced Complexity, Time and Cost

Our 300+ Regulatory and Market Access experts based centrally and regional countries across 70+ key global markets have helped thousands of pharmaceutical, medical devices, diagnostics, cosmetics, nutraceuticals, supplements and veterinary products successfully develop their labelling and promotional material as well as maintain compliance through reviews. Coupled with Artixio’s regulatory intelligence-based services platform, innovators and manufacturers from around the world have benefited by managing the ad promo strategy seamlessly.

Work with Artixio’s Local Experts, Deliver Globally

Successfully Managing compliance for promotional material for 200+ products annually
Subject Matter Expertise across Medical, Regulatory, Labeling, Marketing & Operations
Diverse Products Experience across Complex Products Categories and Therapeutic Areas
Strong Regional Expertise in 120+ markets with 15-35 years of experience
Health Authority Experience in Navigating through Complex, often Ambiguous Regulations
Intelligence driven, global pharmacoviglance services supported by regulatory intelligence platform, Dvarka
ISO 9001:2015 quality standards governed services
Customer focused, flexible services and solutions
Flexible Business Model including project based, managed services and FTE staffing model
Hybrid-Local-Centralized Support across Safety functions

FAQS

What are key components of global advertisement and promotional material review?

Global advertisement and promotional material review is performed to ensure patient safety through accurate, clear and effective communication of product information through product labels (Core data sheet (CDS), Product information leaflet (PIL), SmPC) and other marketing and promotional material. The key components of ad promo review include Medical, Regulatory, Legal and Marketing review of material to ensure the information provided in the material are medically accurate, evidence based and present facts in true manner. Further, the material must comply with local laws, guidelines and regulations for promotional material while being in line with company’s medical and marketing strategy.

How do you support Ad Promo Review across multiple countries?

Artixio’s regulatory intelligence platform is regularly updated with regulations from global health authorities including any new changes in regulations related to product labelling, advertisement and promotional materials for pharmaceutical products. Coupled with Artixio’s medical, regulatory experts based in 70+ countries and experience in successfully registering and maintaining compliance for complex products, centralized global project management best practices, Artixio supports Advertisement and Promotional Material Review across multiple countries.

How does your Regulatory Team manage international submissions for Labeling, Artwork, Adertisement and Promotional Materials?

Our regulatory experts are based locally in key markets globally with 15-35 years of experience in successfully developing, reviewing and submitting the labelling, artwork, advertisement and promotional material for product such as pharmaceuticals, biologics, devices for diverse and complex therapeutic areas.

What challenges do companies face in global ad promo review and how do you address them?

Companies face multiple challenges including lack of complete understanding of laws, regulations and guidelines for labelling, advertisement and promotional materials, lack of experienced teams in the country/region, lack of necessary tools, standard operating procedures (SOPs) for managing the ad promo lifecycle, urgent submissions/ event promotions that require quick review from seasoned, regional experts, lack of visibility of volume of work to deploy resources for long term ad promo operations management, timelines and budget.

How do you stay updated with global regulatory changes impacting labelling, advertisement and promotional materials?

Artixio has internal regulatory intelligence platform, Dvarka, that tracks global regulatory changes that may potentially impact the pharmaceutical product label, ad and promo strategy and material. The platform hosts,

Current regulations, directives, regulatory insights
Track changes in regulations, new guidelines, notifications from health authorities worldwide
Insights by our Regional Regulatory Experts from their experience, attendance to Conference, Seminars, Trade Shows, HA Organized Trainings and Events
Artixio’s expert opinions and Case Studies from medical, regulatory, legal and marketing perspectives