AREAS OF PRACTICELife Sciences

Our experience in advising Pharmaceuticals, Health Products and Biotechnology (Life Sciences) has made us well known among universities, biotech and medical research institutes, and biotechnology startups. We have recently provided a molecular neuroimaging company with legal advice regarding geographical expansion and joint ventures. We also drafted the approved legislation for the Law on Science, Technology and Innovation in Spain

Regulatory

  • Authorization procedures; and medicine and medical device registration and pricing systems
  • Labeling and packaging of drugs and medical devices
  • Public Administrations proceedings related to drugs, medical devices, and prescribing and dispensing conditions. Challenging general provisions that affect the price-reference system
  • Compliance in the field of special medicines(vaccines, drugs of human origin, advanced therapeutic medicinal products, etc.)
  • Procurement procedures and permit modification for the installation and development of laboratory activities
  • Product Liability

Commercial Compliance

  • Advice on legal compliance and ethical standards in medicines and health products
  • Internal procedures and protocols that facilitate compliance with advertising-field obligations
  • Contracts that provide services with health professionals that comply with the provisions established by the Code of Good Practices (FENIN), and the Spanish Code of Practice, which deals with the promotion of medicines, and with the pharmaceutical-industry’s interaction with healthcare professionals
  • Review of all mediums of promotional materials produced by companies
  • Website evaluation (analysis of advertising content provided to the general public and health professionals, and review of requirements for making some content available to health professionals only)

Research and Pharmacovigilance

The development of research activity is inherently linked to the pharmaceutical and healthcare sector. At RCD we provide a deep understanding of this matter and its implications in both the public and private scope, enabling us to offer the following services:

  • Contracts linked to the development of clinical trials and observational studies (EPA and non-EPA), either with researchers and research centers, CROs, or other third-party service providers in the health field
  • Drafting of informed consent documents
  • Design of appropriate investigative protocols for legal framework of investigation.
  • Advice for activities related to biomedical research: genetic studies, biobanking legal systems, extraction systems, and the utilization, processing, and storage of tissues and cells in the context of research activity
  • Advice for processes related to extraction, preservation, and application or implementation of human organs and tissues
  • Assistance in meeting pharmacovigilance-activity obligations

Protection of personal data

Design and implementation of project adaptation so that activities with therapeutic, diagnostic or research purposes (such as treatments implemented by pharmaceutical laboratories, and the treatment of human biological samples (cells and tissues) will suitably follow protection-of-personal-data regulations.

  • Adherence to the regulation on the protection of personal data for hospitals and other healthcare facilities
  • Advice on procedures for the adherence to the Pharmaindustry Code for personal data protection in the field of clinical and pharmacovigilance research
  • Advice on the enforcement of data protection and patient autonomy in the context of clinical trials
  • Development of confidentiality agreements and data access between third parties and CROs or research teams
  • Legal advice on the procedures for the implementation of ICT in care-related activity (digital medical records, electronic prescribing, telemedicine and telecare)