The Life Sciences team includes practitioners trained in diverse areas with extensive experience working and negotiating with local regulatory agencies on matters of licenses, as well as regulatory implementation of mergers and acquisitions, product registries, queries on application of health rules, distribution agreements, imports and exports, litigation, and Intellectual Property matters.
FERRERE stays on top of new trends, along with regulatory opportunities and threats. Its practitioners coordinate efforts with its clients’ technical staff, which is simple in light of the firm’s deep knowledge of the industry, beyond legal aspects. This accrued knowledge and experience is what major local, regional and international players take into account when selecting the firm.
Specialties:
- Company authorizations and product registries
- Handling complex situations: product entry, withholding and recalls
- Aspects related to product composition, manufacturing, transportation, conservation and handling
- Company registry management, signature authorizations, filings and changes
- Labeling and advertising reviews
- Negotiation and drafting of agreements on product quality control, manufacturing, warehousing, transport and distribution
- Followup, analysis and reporting on new regulations and their impact on the industry
- Health care systems, authorization requirements according to provider category
- Health care advertising
- Requirements for incorporation of medical technology
- Technology assessments
- Mandatory coverages (services and drugs)
- Electronic prescriptions
- Medical histories (records, conservation and support) and e-histories
- Informed consent and clinical studies
- On-line medical queries and analysis of extra-territorial service