Our SERVICES

Health & Regulatory Affairs

Behind the development of every new health product and service lies an extensive and strict set of regulations. It is crucial that your company objectives align with these local and international regulatory frameworks. Our expertise in health sector regulations ensures that you overcome this barrier to market.

We’ve achieved global recognition for a reason
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How Can We Help You?

Our approach to the healthcare and life science sector involves extreme care and precision. We work on critical regulatory issues with a wide range of industry participants - from healthcare professionals in multinationals and SME’s to those within startups and universities. Our attorneys continue to provide comprehensive coverage in all matters within this highly regulated sector, including Intellectual property, antitrust, product liability, clinical trial compliance, marketing authorizations, and more. We respond to policy and legislative changes, new and innovative models of practice, and increased digitalization - on your behalf.

Our Services

  • We work with highly innovative biotech firms on regulatory matters surrounding R&D and other issues such as market access. Our professionals are well-positioned to devise strategies in various areas, from plant breeding rights to licensing and cross-licensing deals.
  • Pharmaceutical businesses turn to us for guidance on their complex legal challenges. Firms face scrutiny from regulators regarding product safety, with health authority approvals becoming an increasingly prominent challenge. We ensure our clients follow compliance.
  • Firms in the medical device industry rely on us for navigation through local and international product requirements. We advise them on a variety of issues from, joint ventures and manufacturing to anti-counterfeiting and recalls. We understand the whole product lifecycle.
  • We advise firms in the food and beverages industry. Our team gives advice and insights on an array of product stages, from production and product labeling to marketing and distribution of products - while always adhering to the FDA and other laws and regulations.
  • Our attorneys are highly experienced in representing businesses in processes and procedures before the Colombian health authorities and other governmental entities e.g. antitrust investigations.
  • We provide highly specialized consulting on regulatory affairs and compliance with regard to product branding and advertising. We also offer audits in certifications such as GMP and CCAA.
  • We can work with firms to obtain toxicological opinions before the INS and obtain access permits to genetic resources. We also advise on Maquila and distribution contracts of products subject to sanitary regulation.

For a fresher outlook on Regulatory Law

Our firm covers every aspect of the global regulatory landscape. We are highly experienced in consumer protection and competition law, having served thousands of clients in the health sector and beyond. Our consumer protection lawyers often help tailor clients' advertising strategies and material to comply with consumer law and marketing jurisdictions set by the government. On the other hand, our competition law attorneys frequently work on antitrust proceedings regarding restraints to the market - they also review contracts to determine potential constraints to competition. The important thing is that changes in global regulation can touch every significant industry. Consequently, decisive action is needed to comply and respond to such change. We prepare you for regulatory changes by not giving legal opinions full of jargon but instead a concise, summarized, and definite opinion that is lighter to read, in-depth, and most importantly, filled with practical solutions. Our team can support your business’s strategy in light of regulatory requirements. We add value to your operations. For more information on our Consumer Protection & Competition Law practice, click the link below.

Consumer Protection & Competition Law Page

Why Cavelier Abogados?

The sector trusts us. Our lawyers draw upon a wealth of experience to provide advice on both contentious and non-contentious issues. Our team continuously monitors the changing Covid-19 law in Colombia and abroad to provide the most up-to-date guidance in clinical trials, medical devices, and market access. We regularly support market-leading organizations with the commercialization of their IP - from contract negotiations to licensing proceedings, your interests are protected. We’re in your corner.

Our TEAM OF PROFESSIONALS

Meet Our Health & Regulatory Affairs Specialists

Our TEAM OF PROFESSIONALS

Meet Our Health & Regulatory Affairs Specialists