Practice Area 08
Pharmaceutical Industry and Life Sciences: Legal Protection for a Highly Specialized Sector with No Room for Error.
Science moves forward; the law supports it. This is how we safeguard your innovation and operations.
Health and sanitary regulation, corporate law, intellectual property, litigation, environmental matters, and compliance for pharmaceutical companies, laboratories, medical device manufacturers, biotech firms, and healthcare providers, within a single working relationship.
The practice area
In a global market, where the interaction between public and private entities is governed by one of the most heavily regulated sectors nationally and internationally, it is essential to capitalize on experience through comprehensive legal solutions and specialized advice delivered with versatility and added value.
At Beristain+Asociados Abogados, we offer full legal protection, comprehensive advisory and support to our clients in the Pharmaceutical and Sanitary Sector regarding a wide range of applications in medical products and devices, sanitary products, biotech, healthcare, and pharmaceuticals for human and animal consumption, as well as their interaction with the health and regulatory sector governing them, including their relationships with research institutions and related medical services.
The broad experience of more than 48 years of the multidisciplinary team at Beristain+Asociados Abogados allows us to provide comprehensive legal and technical solutions, integrating various areas of public and private Law, such as Intellectual and Industrial Property, Administrative Law, Corporate Law, Civil and Commercial Law, Environmental Law, Tax Law, Criminal Law, Foreign Trade, Governance, Compliance, and international best practices, among others, based on a tailored analysis and diagnosis and on the real needs and requirements of our clients.
What this area covers
What does this practice area cover?
REGULATORY AND COMPLIANCE
- Advice on, and compliance with, the provisions of the General Health Law and its regulations, Official Standards, and other applicable legislation.
- Processing, follow-up, and handling of permits, authorizations, and health registrations before COFEPRIS, the Ministry of Health, SENASICA, and other authorities.
- Compliance with PROFECO and its regulations, as well as matters relating to consumer rights.
- Registration of pharmaceuticals and medical devices.
- Regulations governing the labeling, packaging, import, and export of health-regulated products.
- Handling of inspection visits and audits conducted by regulatory authorities at the three levels of government.
CORPORATE AND INTELLECTUAL PROPERTY
- Mergers, acquisitions, spin-offs, corporate restructurings, etc.
- Drafting and review of national and international manufacturing (maquila), distribution, and marketing agreements.
- Economic competition (antitrust) analysis.
- Patents, trademarks, utility models, research protocols, etc.
- Advice on public and private tenders.
LITIGATION, ENVIRONMENTAL, AND LIABILITY
- Administrative and contentious proceedings, litigation, constitutional relief proceedings (amparo), complaints, and resolutions before various authorities (COFEPRIS, CONAGUA, ASEA, SEMARNAT, etc.).
- Environmental licenses, Environmental Impact Statements, and Environmental Risk Studies at the municipal, state, and federal level.
- Operating licenses, construction permits, civil protection matters, and municipal, state, and federal permits and regulations.
- Advice on moral damages, civil liability, class actions, and insurance.
- Advice on, and negotiation of, domestic and international insurance policies tailored to the client’s product risk and operations.
OPERATIONS AND VALUE CHAIN
- Comprehensive energy solutions for plants and corporations.
- Ongoing support and comprehensive legal advice aimed at providing our clients with legal protection throughout the entire operating chain, from manufacturing and production through distribution and trading.
Authorities
Entities we interact with
Much of the work in this practice area takes place before authorities and regulatory bodies. Tell us about your case, and we will let you know which ones apply to your case.
Some of the entities we interact with include the Ministry of Health, SEMARNAT, the Ministry of Economy, ASEA, COFEPRIS, PROFECO, Customs (ADUANAS), verification units, and other related regulatory bodies and decentralized agencies.
Contact
A health or regulatory matter pending?
Describe it in the form below, and we will appoint it to the appropriate practice area. If a deadline is running, please call.