Bionical Emas have a highly experienced team of scientific, medical and compliance reviewers, including final medical signatories, and we can provide 24/7 Medical Monitoring cover and Medical Information services.
The Bionical Emas Medical and Scientific Services Team understands the needs of the client in conjunction with customers, and critically with payers, regulators, prescribers and patients. Our international experience offers a comprehensive support package. Collectively, our senior medical and scientific staff have been operating in the industry for decades and have a broad experience dealing with different issues that can arise within the sector.
We believe in working with all stakeholders to gain the best results. We will work with you to provide one-off support, to bridge a temporary gap, or provide a complete service.
Bionical Emas Medical Affairs services:
- Medical monitoring support up to 24 hours a day
- Medical review of ICSRs, along with review of regulatory documents
- Medical/Scientific review of promotional and educational materials including medical final sign-off
- Advice on ABPI/ European Code compliance
- ABPI complaint support and handling
- Medical Information services
- Maintenance of knowledge base/literature review
- SOP/WIs preparation
- ABPI Code advice/training
- Broad therapy area knowledge/expertise
Medical monitoring and medical review.
Our support includes protocol development; medical monitoring activities including planning; signal detection and management; and medical review of the ICSRs (Individual case safety report) including SUSARs regulatory documents reviews including RMP, PSUR, DSUR, CSR etc.
Patient safety is our priority and we can provide 24/7 medical monitoring and medical information services.
Medical and scientific review and approval of promotional material and activities.
Bionical Emas have a highly experienced team of scientific, medical and compliance reviewers, including final medical signatories, to ensure promotional activities are compliant with regulations, consistent with product labelling and are medically and scientifically accurate.
We can provide support in different ways depending on your needs and processes. We can undertake full technical, regulatory, medical and scientific review and approval, or a one-off review. For example, if our client intends to keep all final sign-off in house we can provide a detailed technical review to support their activity.
We have over 20 years’ experience working with the UK Code of Practice and have knowledge and experience of other European codes including reviewing and approving core EU materials for use/adaptation in a number of EU countries.
We like to work closely with clients and their agencies, providing early input, usually at the material/activity development phase, to ensure efficient approval.
- From kick-off meeting to SIV in five days – a severe COVID-19 pneumonia case-study Explore
- Effective Pharmacovigilance & Regulatory EU and Australian Due Diligence, leading to operational and consultative support Explore
- Bionical Emas Regulatory Affairs: Mutual Recognition Submission Strategy Explore
- View all