Advertisement and Promotional Material Compliance Services
Your Partner for Global Medical and Regulatory Compliance Ad Promo Materials. We help review promotional material for medicinal products to check if it meets compliance standards before it reaches the market.
Services We Offer
Key Ad Promo Compliance Areas We Focus On
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.
Our Ad & Promo Compliance Services Include
- 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
How We Support Your Promotional Materials Review Process
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
Scope of Our Ad & Promo Compliance Review Services
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.
Enabling Access to Innovation Globally
Driven by key regional regulatory and market insights, Artixio aims to enable seamless access to lifesciences innovations for patients and end users globally.
Ensuring Compliance
Our centralized view of global regulations and strategies to approach diverse, complex markets enable us to ensure compliance of multiple products across multiple markets on ongoing basis.
Commitment to Excellence
With proven experience from successful approvals and key learnings from different markets across product and therapeutic categories, Artixio is committed to excellence by implementing best management and regulatory practices geared towards efficient, reliable solutions for our customers’ regulatory needs.
Why Choose Artixio for Promo Material Review
- 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
Still Have Questions ?
Get expert answers tailored to your needs.
Specialized Advertisement and Promotional Material Review Services Services Across Multiple Industries
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
Expert Regulatory Services To Streamline Compliance
Regulatory Intelligence & Strategy
Medical & Technical Writing
Publishing & Submission
Product Registration
Investigation New Drug Application (IND)
New Drug Application (NDA)
Post Approval Lifecycle Maintenance
Artwork and Label Review
Ad Promo Review
Regulatory Affairs Across Multiple Countries
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
European
Thailand
Indonesia
Philippines
USA
Japan
Qatar
South Korea
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