Promotional material review with regulatory precision
Get your promotional materials ready for the market with expert regulatory review
How can Asphalion support you
Asphalion supports pharma, biotech and medtech teams with expert review of promotional and scientific materials across Spain and Europe, providing practical and reliable guidance for Human Medicines, Medical Devices, and Food Supplements.
We assess that claims, references, disclaimers and messages meet the applicable regulatory requirements — clearly, efficiently and with deep knowledge of current guidelines.
Our services include:
Regulatory and medical review
We review promotional and non-promotional materials from both a regulatory and scientific perspective to help ensure alignment with applicable requirements, local codes, and internal standards defined by our clients.
Our support covers both traditional and digital materials, including a wide range of formats such as brochures, promotional leaflets, campaigns, congress materials, email communications, posters, scientific presentations, claims, advertisements, videos, websites, among others.
As part of the review process, we assess:
- Compliance with applicable local requirements and codes.
- Scientific accuracy.
- Consistency of content.
- Appropriateness of the message for the intended audience and use.
We apply a consistent and risk-based approach, considering the complexity and sensitivity of each material and assigning expert profiles according to the type of content and associated compliance risk.
Website compliance and digital presence
Digital channels require the same level of control and compliance as offline promotional materials. We support the review of websites and digital content to achieve alignment with applicable regulations and guidance.
Direct liaison with regulatory authorities
When needed, our team acts as a direct point of contact with regulatory authorities and relevant local industry associations, supporting the submission of materials, and helping clients manage communications efficiently and effectively.
Digital review tools
- We have wide experience in the management of promotional material review processes through digital review tools, collaborating in a more efficient workflow while maintaining full visibility throughout the review and approval steps.
SOP development support
A robust internal process is essential for compliant promotional activities. We provide support in the development of Standard Operating Procedures (SOPs) to help companies establish or strengthen internal review processes and responsibilities.
Tailored training
We provide tailored training sessions designed to strengthen your team’s understanding of promotional material requirements and compliance expectations. These sessions can help improve consistency, awareness, and day-to-day decision-making.
Regulatory intelligence
We help clients stay informed through regulatory intelligence support, providing timely updates and insights on compliance requirements, and changes in the legal and regulatory landscape.
Global reach, local expertise
Asphalion supports clients worldwide with the review of materials, ensuring compliance with applicable local requirements and market practices within the EU.
Our local support is tailored to each market. In Spain, for example, this may include:
- Review of promotional and non-promotional materials in accordance with applicable legislation and local requirements.
- Alignment with the Farmaindustria Code of Good Practice.
- Scientific and medical accuracy.
- Submissions of materials to the relevant competent authorities and industry associations, where required.
- Scientific Service signature, if required.
Areas covered
Asphalion supports promotional material review and compliance activities across multiple healthcare sectors, including:
Our compliance framework
Our support is based on a detailed understanding of the applicable regulatory environment, including:
- National applicable legislation
- EFPIA Code of Good Practices (including national adaptations)
- Local regulatory guidance
Why Asphalion
With a team of regulatory and scientific experts supporting clients across Europe, Asphalion provides practical, reliable, and tailored support for promotional material compliance. We help clients strengthen review processes, mitigate regulatory and compliance risks, and support the timely execution of promotional and scientific activities.
How we work
Send us your materials, we assess the compliance risks according to country legislation, and you receive actionable feedback to move forward with confidence.
Talk to a regulatory specialist
Why Asphalion?
ASPHALION offers expert consulting, strategic advice, operational support and full outsourcing services for all drug development stages
ASPHALION’s experts have delivered solutions to over 1,500 Pharmaceutical, Biotechnological and Medical Technology companies from more than 50+ countries in over 10,000 projects covering non-clinical and clinical development, CMC, dossier writing, regulatory procedures, vigilance, eSubmissions and data management for both medicinal products and medical devices.
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