Expert Solutions for Legal Compliance in Biomedical Communications
Too many promotional material? Moreover, you are not sure whether they all comply with the Polish law?
Do you want to avoid risk and your lawyers, as always, hesitate in giving you a specific and precise answer, because lack scientific knowledge in the field of biomedical sciences and lack of practical regulatory affairs experience is narrowing their view?
Your regulatory affairs team can’t cope and marketers are constantly pushing you for faster review and approval? We know how to solve that.
This is a good address, we will help you and your company to be efficient in communicating and minimize risk of noncompliance! Our experts have reviewed and approved 3000+ promotional materials ensuring compliant communication to the HCP’s, Patients and Customers.
With complex marketing guidelines, legislation and different ethical framework in Poland, a local review to ensure your promotional material adheres to the national codes would be essential. Reputation is important in the pharmaceutical industry. In KMJ pharma® you will find an independent and experienced partner with local expertise able to present solutions.
We provide review on promotional material/activities related to human and veterinary products, including medical devices, herbal medicinal products, food supplements, and cosmetic products in Poland. Our experienced consultants will guide you through the process and ensure the final result is both compliant and effective.
We continuously monitor the current ethical framework, marketing guidelines and legislation in Poland, in addition to the EU legislation, guidance under the EFPIA / AESGP / INFARMA / PZPPF / PASMI Codes of Practices.
Integrated Regulatory Compliance Services
Audit and assessment
Conduct audits and assessments of a company’s advertising and promotion practices to identify areas of potential non-compliance. Review promotional materials and procedures and provide recommendations for improvement.
Training
Provide training to company employees on regulations and codes of practice related to advertising and promotion. This can help ensure that all employees are aware of the rules and guidelines and know how to comply with them.
Compliance monitoring
Monitor a company’s advertising and promotion practices on an ongoing basis to ensure ongoing compliance. This can include reviewing promotional materials, attending events and meetings, and conducting mystery shopping exercises to identify potential breaches.
Regulatory and Medical Review support
Provide support and guidance to companies for the review of all commercial and medical materials as well as serving as an expert, work with regulatory authorities on promotional enforcement actions, preparing for regulatory inspections, and navigating complex regulatory promotional requirements.
Process improvement
Help companies improve their processes and procedures for advertising and promotion to ensure ongoing compliance. This can include developing policies and procedures, implementing new technologies, and providing ongoing support and advice.
Comprehensive Solutions for Regulatory Excellence in Biomedical Communications
- Evaluation and review of scientific references
- Preparation of Abbreviated SPC/Catalogue text (SIOL)
- Submission of marketing material to authorities
- Translation of marketing material including review
- We have regular dialogue with the Health Authorities
- We have significant experience with Veeva Vault PromoMats and ZINC
