Pharmaceutical and Biotechnology Regulatory Law

Legal consultancy in health and pharmaceutical regulatory law

Clinical Trials with drugs (RD 1090/2015), Clinical Trials with Health Products (Medical Devices), Clinical Trial with Food Products, etc.

Legal consultancy in Observational Studies and Post-Authorisation Study (EPA-PAS) Order SAS/3470/2009).

Research project, Sample Transfer or Assignment (Biomedical Research Law 14/2007), etc.

Drug marketing authorisations, “Priority Review Voucher”, etc.

Legal consultancy in legal aspects regarding drugs, health products and "medical device".

Revision and drafting of contracts

Research Project, Clinical Trial, Observational and Post-Authorisation Study Contracts, etc.

License and technology transfer contracts.

Co-development and collaboration contracts.

Material Transfer Agreements (MTA).

Sample assignment or transfer contracts.

Legal consultancy in legal aspects regarding drugs, health products and "medical device".

Consortium agreements or contracts (including joint venture agreements, etc.)

Patient informed consent.

Contracts for the provision of services.

Contract Negotiation.

All types of addenda and contracts.

Personal Data Protection

Consultancy in LOPD and European Regulation on Data Protection.

Consultancy in Data Protection for biomedical research projects and patient data.

Drafting of contracts related to treatment.

Analysis of health-related data protection in Clinical Trials, informed consent, Ethics Committee of the Clinical Research, etc.

Security documents.

Support in Clinical Trials

This form implies clinical trial contracts being studied by a team with extensive experience in drafting and reviewing Clinical Trial contracts.

This service is addressed to pharmaceutical laboratories, health technology companies, CROs, research centres and all companies and suppliers of the pharmaceutical and health industry that require a specialised lawyer in Pharmaceutical and Sanitary Law in order to act in coordination with other departments.

Contract negotiation and revision with the centres, adapted to the requirements of each Autonomous Community.

Consultancy in the application and implementation of Royal Decree 1090/2015.

Contract negotiation and revision with the main researcher.

Drafting and revision of consent documents in order to comply with the data protection legislation.

Contract negotiation and revision with the CRO.

Find out how we can help you in your life sciences sector