Compliance made clear
While in most international jurisdictions there is a legal basis for healthcare compliance, in practice it is common for the most comprehensive requirements concerning the advertising and promotion of medicines and other materials to be set out in codes of practice, i.e. under a voluntary system of regulation supported by bodies that help administer the codes. 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 Europe, 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. We aim to understand your commercial objectives so that both compliance and promotional effectiveness are achieved; with our constructive approach, we often advise on alternative solutions that achieve objectives. 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. Our experts have successfully helped many companies with making and receiving complaints, investigations, appeals and audits.
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
For example, in the UK we have supported 5 of the 6 UK companies audited in 2017, 2018 & 2019 by the PMCPA – and 3 of the 4 companies being audited in 2020.
Medical Approval is the review and approval of promotional and non-promotional materials and activities.
Our services include:
- Outsourced uploading, review and certification
- Medical advice
- Non-medical signatories
- Undertakings documents
- Claims documents
Our account management allows you to access commercial dashboard statistics, so that medical support is utilized optimally.
What our clients say
I have found the quality of both work and personnel to be unparalleled. Rina and the team have taken much time and care to understand our business and brand objectives. They have worked tirelessly to assist with a solutions-based focus and have maintained extremely high standards to support us. I cannot imagine another supplier providing this level of service.
National Professional Relations Manager, AstraZeneca
Rina and the team were brought in to help support us during the PMCPA complaint process and subsequent audits. Their expertise and approachability made this difficult process smooth. True professionals and a pleasure to work with!
Head of Ethics and Compliance, Astellas Pharma Europe