Pharmaceutical and Life Sciences Law

Pharmaceutical Law and Regulatory

Pharmaceutical and Life Sciences Law

Pharmaceutical and Life Sciences Law

Our firm is considered to be the leading firm in Spain in the treatment of the legal aspects related to the administrative regulations applicable to the activities of pharmaceutical and health care industries in general.

In this sector, we offer services of strategic counselling, focusing specifically on the analysis of the opportunities and risks stemming from the legislative and regulatory environment and its modifications, and on the possible intervention in decisive procedures on a legislative and administrative level.

We also offer preventative consulting services and handling of cases in topics such as:

  • Laboratory authorization and technical guidance. Management of operations directly or through third parties.
  • Clinical trials.
  • Marketing authorisation procedures. Review of cases involving the company or competitors, specifically those referring to the approval of generic medicines.
  • Access to market, compassionate use, and foreign medicines.
  • Transfer of marketing authorizations.
  • Public Financing. Management of situations of admission or exclusion of reimbursement of specific products; and advice on legal aspects relating to medicine’s pricing.
  • Distribution and supply. Management of crisis situations provoked by parallel marketing of products.
  • Pharmacovigilance.
  • Withdrawal and suspension of marketing of specific products.

Our intervention in these areas encompasses the design of legal strategies to be followed in relation to specific projects as well as actions to be taken before administrative authorities during proceedings and, should it be necessary, the filing of administrative appeals.

Likewise, we have experience in representing pharmaceutical companies in Court proceedings against public authorities.

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