Life Sciences - Brazil
Band 3
What the Team is Known For
SPLaw offers solid experience in life sciences regulatory mandates. The firm assists with clinical trials, distribution agreements and licensing for national and international clients. It also handles compliance matters and product registration before ANVISA.
Strengths
SPLaw stands out for its level of knowledge and depth, as well as its understanding of our dynamics as a company. On advisory matters, the team provides guidance that is closely tailored to our needs, without excessive legalism.
We praise SPLaw for its flexibility, prompt responsiveness, fair pricing and in-depth technical knowledge. The team is able to fully support us across all our matters, without the need for us to work with other law firms.
SPLaw is recognised for its solid expertise in sanitary regulation, knowledge of ANVISA standards and practices, and objective guidance aligned with the company’s needs.
Work Highlights
SPLaw advised Sandoz on the design of a single, end-to-end structure to localise the production of a 3.75mg leuprorelin acetate product through a PDP (productive development partnership) with a state-owned pharmaceutical manufacturer while preserving Sandoz’s regulatory and IP positions.
Notable practitioners
Benny Spiewak has experience advising companies on life sciences regulatory matters involving clinical trials, compliance and distribution matters.
Benny Spiewak is the best lawyer I've ever known, in every aspect.
Benny Spiewak is very creative and has sector knowledge that inspires a great deal of confidence. He also has extensive expertise in the pharmaceutical industry, which he is able to leverage well.
