Legal & Bioethics  

Through many years of experience and involvement with the pharmaceutical industry, we have the expertise to advise and support you on key legal, regulatory and bioethical issues and provide solutions on contracting and third parties interactions.

The quality of our services is based on industry expertise, understanding the specifics of the functioning of the legal system, adopting individual and partnership attitude to each client, while complying with high professional and ethical standards and being technologically efficient in working with information.

Pharmaceutical / Medical Devices

Pharmaceutical Legislation and Regulation (approval, pricing, marketing- advertising, health technology assessment, reimbursement)

Medical Devices Legislation and Regulation (approval, CE marking, product classification, reimbursement)

Contracting concerning needs of pharma and medical technology industry to access market, promote and receive reimbursement for pharmaceutical products and medical devices (in-licencing, co-promotion, reimbursement, marketing, partnering)

Interactions with third parties

Legislation / Regulation concerning relationships of pharma industry with Healthcare Professionals (HCPS), Healthcare Organizations (HCOs) and patients

Code of Ethics (European Federation of Pharmaceutical Industries and Associations (EFPIA), Hellenic Association of Pharmaceutical Companies (SFEE), Medical Ethics)

Interactions with Healthcare Professionals (HCPs) or Healthcare Organizations (HCOs) (advisory boards, participation in scientific events / conferences, other services)

Contracting with KOLs (legal & deontology obligations/ restrictions, special categories (NHS, Universities), honoraria / fees, transparency and disclosure of transfers of value, conflicts of interest, personal data protection, anti-bribery, confidentiality)

Interactions with patients / patient organizations

Research & Development

Legislation of Clinical Studies

Regulatory Issues

Human Rights

Principles of Bioethics

Ethics of Animal Studies

Ethics of Ηuman Studies