Client Alert | May 17, 2023
Peru: Regulation for the registration and re-registration of certain biological products are approved
Healthcare & Life Sciences
- Health and product authorizations: reviewing, preparing, filing and prosecuting different health and product authorizations and notification processes required for the manufacturing, importation, distribution and commercialization of pharmaceuticals, medical devices, cosmetics and foods.
- Advertising and marketing: We advise on regulations, standards and codes of practice relating to marketing and promotion of pharmaceutical products and medical devices.
- Clinical trials: We work with clients on legal, contractual and regulatory issues through all phases of clinical trials.
- Data privacy: We help assure compliance with data protection and privacy laws, including the observance of informed consent requirements and contractual implementation of confidentiality duties.
- Promotion to professionals: We advise on permissible practices regarding marketing to and sponsoring of health professionals.
- R&D centers: We help establish R&D centers, including structuring IP ownership, setting up employment invention programs and developing local and cross-border tax and fiscal strategies.
- Regulatory compliance: We assist at all stages of compliance, from early stage general operations, licensure, research and clinical trials to marketing. We also defend enforcement actions and investigations.
- Biotech initiatives: We advise on financing, acquisitions, spin-offs, strategic alliances, joint ventures, licensing and other collaborations essential to biotech initiatives.
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Chambers & Partners
Practices 2021 2022 2023 Healthcare & Life Sciences Band 2 Band 2 Band 2 Testimonials
Band 2: Chambers and Partners — 2023
Estudio Echecopar - Baker McKenzie boasts a well-resourced and established team possessing expertise acting on complex matters such as sanitary registrations as well as regulatory and compliance advice. The department is also able to offer skills in judicial proceedings and bureaucratic barriers. The firm is frequently instructed by clients active in the food and beverage, pharmaceutical and cosmetics sectors.
Strengths "Estudio Echecopar - Baker McKenzie has an excellent team in the Peruvian life sciences sphere."Band 2: Chambers and Partners — 2020
"They are competent, have ample knowledge of Peruvian and international regulations and are at the forefront of regulatory initiatives."
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The Legal 500
Practices 2023 - - Healthcare & Life Sciences Band 2 - - Testimonials
Band 2: The Legal 500 — 2023
Estudio Echecopar member firm of Baker McKenzie International handles a broad range of corporate and regulatory matters for large international companies and smaller domestic businesses in the pharmaceutical, medical device, cosmetics, and food and beverage sectors, among others. Key areas of focus for the practice include advertising and marketing, regulatory compliance, and -on the corporate side- financing, acquisitions, spin-offs, joint ventures and licensing issues. Practice co-heads Luis Alonso Garcia and Alvaro Gutiérrez are both recommended for IP-related healthcare and life sciences work, including matters concerning sanitary regulations. Gonzalo Bernal brings expertise in trade and commerce to the team and has particular experience of World Trade Organisation regulations and customs matters. Associate Rosemary Rivera handles both contentious and non-contentious IP matters.
‘For consultation and advice on the issues that we work with, in particular regulations and tax matters, they are very competent‘.
‘We work with Alvaro Gutierrez’s team, they are very fast, they investigate thoroughly and send early warnings when there are changes in the future’.
Description
We have developed a global healthcare industry group with regional sub-groups in North America, Latin America, Europe, and Asia-Pacific. The lawyers in our industry group specialize in providing service to global, diversified, healthcare clients and as a result we know what you need and require and as a team we have the capability and experience to assist you in furthering your preeminent leadership position in global diversified healthcare and consumer products.