Promotional Materials & Compliance
Pharmalex is your strategic partner to meet your goals for worldwide promotional material review and validation for drugs and medical devices.
We provide a broad range of services linked to the review of promotional material for international congresses and local compliance. We will advise on and review activities and processes for healthcare compliance that fall under the EFPIA Code of Practice as well as national codes, practices and legislation. With our constructive approach, we often advise on alternative solutions that achieve objectives
Contact our specialists to tailor a service plan
Where national requirements require the submission of certain materials to local health authorities, our combined regulatory and medical expertise is also highly valued by our clients.
Furthermore, if you find yourself facing an authority inspection, our experienced audit team can assess your situation and provide you with actionable outputs so you can identify, correct and prevent risk.
These flexible solutions range from an integrated package of services, to adapted ad-hoc regulatory and technical support.
We aim to understand your commercial objectives so that both compliance and promotional effectiveness are achieved . Our goal is to explore innovative approaches and provide relevant advice to ensure you maintain your competitiveness in this complex and changing regulatory environment.
Our experts have successfully helped many companies with making and receiving complaints, investigations, appeals and audits.
Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.
Our Services include
Regulatory and medical review and validation of all advertising and promotional materials at the global and local level with:
- One identified project manager as your central contact point and campaign oversight co-ordinating all worldwide activities with all stakeholders including KPIs & metrics to ensure high quality of deliverables as per agreed timelines.
- A Pharmalex expert team / Global scientific officer dedicated to your products for the European/global review and validation of your materials.
- A worldwide highly qualified internal resources and network of local partners, providing the services of local signatories / person responsible as required in line with local requirements (e.g. The Association of the British Pharmaceutical Industry (ABPI) signatory in the United Kingdom, Information Officer (Informationsbeauftragter) in Germany, Regulatory Scientific Services in Italy and Responsible Pharmacist in France, Advertising and Promotion ‘AdPromo’ guidance FDA in USA)
- Support on the full set up, training and validation of your procedures: write or review Standard Operating Procedures (SOPs) and working instructions on a global and national level.
- Provide advice on the software workflow for each market taking into account the local requirements for review, approval and signature of promotional items.
- Provide training on promotional material review and validation requirements for global and/or local requirements. We offer e-Learning, Workshops, Webinars etc…
Management of the review and validation of all types of promotional materials in local languages and in client systems such as Veeva®, Trackwise® and so on.
- Clear, 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 as required at a national level
Healthcare compliance activities
Healthcare compliance is the adherence to codes and legislation governing the advertising of medicines.
Our services include:
- e-Learning courses
- Code training
- SOP creation and review
- Complaints, advice and investigations
- Audits (compliance or specific areas)
- Interim compliance managers
- Compliance programs
We manage material according to local market requirements but a broad list of applicable codes of practice include International Federation of Pharmaceutical Manufacturers and Associations (IFPMA code), WHO Resolution Ethical Criteria for Medicinal Drug Promotion, European Federation of Pharmaceutical Industries and Associations (EFPIA code), and local regulations such as the Association of the British Pharmaceutical Industry (ABPI code), French National Agency for the Safety of Medicines and Health Products (ANSM) recommendations, Medicines Australia Code of Conduct, the Brazilian National Health Surveillance Agency (ANVISA) and the Federal Food, Drug and Cosmetic Act or Medical Devices Laws.
Our clients range from start-ups to global pharmaceutical companies, requiring a temporary or permanent need for support with activities concerning promotional material review and validation.
With their broad therapeutic experience, our experts are highly experienced in the review and approval of all materials that fall within the scope of applicable codes including promotional and non-promotional items, and internal materials. In addition, the expert reviewers provide further guidance based on their local experience to guide companies through the complex and diverse local requirements which are often challenging for global project teams to align campaigns and/or materials.
Available Resources
FURTHER RESOURCES
Related Services
Agency Interactions
PharmaLex has long-standing and extensive experience of interacting with the scientific committees and working parties of the FDA, EMA (e.g. CHMP, PRAC, COMP, PDCO, CAT) and with national Health Authorities. We frequently support our clients in Scientific Advice procedures at a national or central level, and in numerous health authority interactions throughout a product’s lifecycle (e.g. requests for PRIME eligibility, Orphan Medicinal Product designations, Pediatric Investigational Plans, Marketing Authorization Applications).
More InfoCMC Biologics
With over 75 CMC consultants across the globe, PharmaLex has substantial CMC expertise across all areas. We are able to offer an integrated solution combining the scientific, technological, non-clinical, clinical and regulatory expertise with our broad global project experience to meet your specific needs, from discovery to licensing and post-approval.
More InfoCMC Services
CMC strategy and documentation plays an important role from early development to authoring of the marketing authorization application dossier. It also extends to change control and maintenance throughout the product lifecycle. Moreover, CMC requirements are complex and different for chemicals, biologicals, biosimilars, herbals or homeopathics. PharmaLex guides you to the best CMC approach for your products in line with health authority requirements and helps you to stay CMC compliant with sustainable processes.
More InfoeCTD, System Operations and Data Management
Ensuring a smooth and effective submission process today goes beyond the old ways of eCTD publishing. For over 15 years, we have led the way in regulatory submissions with an evolving holistic approach that includes everything from planning to embedded quality control. Of course, all of our services are complemented by state-of-the-art digital facilitation.
More InfoPost-Approval Maintenance
Whether you are interested in outsourcing portfolio maintenance, require support during a merger and acquisition phase, need assistance covering your pharmacovigilance obligations or in development and implementation of your QMS—our Post-approval solutions provide trusted, strategic ways, as well as hands-on support, to keep your product compliant and moving forward.
More InfoRegulatory Writing / Scientific and Technical Writing
PharmaLex offers scientific, regulatory and technical writing, supporting clients in the development of medicinal products.
More InfoContact Us
Contact Form
Complete this form to stay in contact with us.
Global Approach
PharmaLex has 60+ offices in 32 countries serving more than 1600 satisfied clients worldwide. Search your nearest office.