Life Sciences | Brigard Urrutia

Description

We combine deep expertise in the healthcare regulatory environment with multidisciplinary legal excellence to provide comprehensive support for your operations, innovation, and growth.

We offer integrated and specialized legal advice across all areas impacting the Life Sciences and Healthcare sector. Our approach brings together a thorough understanding of the regulatory framework with the multidisciplinary experience of our team, enabling us to anticipate risks, design tailored solutions, and support our clients in strengthening and expanding their operations within a highly regulated and competitive environment.

Service Portfolio

Corporate, Contractual and Commercial Industry Channels

Assessment of requirements for starting operations in Colombia, including applicable regulations and obligations in corporate, business, production, and commercial matters.
Advisory on the structuring, negotiation, and execution of contractual models and commercial strategies for the commercialization, supply, and/or distribution of products and services (e.g., pre-judicial portfolio, direct sales to EPS, sales to wholesalers and institutional channels, tenders, commercial discounts, and other go-to-market strategies).
Advisory on structuring contracts with suppliers and other strategic industry players (patient programs, logistics/supply chain, market access, regulatory providers, collaboration agreements, diagnostic testing contracts, healthcare service agreements, clinical study contracts, among others).
Advisory on import and export processes of goods, products, and services such as medical devices, medicines, medical supplies, specialized instrumentation, among others.
Advisory on the structuring and tax optimization of legal entities and business lines (including VAT exclusions or exemptions, industry and commerce tax, among others).
Support in internal restructuring processes (intercompany/intragroup) of companies within the industry.
Advisory on structuring and analyzing guarantees, and support in negotiations to mitigate credit risks and establish payment agreements.

Regulatory and health compliance

Consulting on health regulations, preparation of technical-legal opinions, and processing of sanitary registrations and certifications applicable to products regulated by INVIMA (Medical Devices and Medicines, among others).
Advisory and management of submissions for pharmacological evaluation studies for new medicines, bioequivalence studies, inclusion of new ingredients in dietary supplements, and new medicinal plants.
Support during technical visits and audits (CCAA) by INVIMA and/or other national health authorities.
Advisory and support in administrative sanctioning processes before INVIMA and the National Superintendency of Health
Environmental regulatory advisory on post-consumption management of expired medicines.

Health System

Advisory and support on matters related to financing, structure, operation, and resource management of the SGSSS (General System of Social Security in Health).
Advisory and support in initiatives or projects involving healthcare professionals and other industry stakeholders, aimed at mitigating ethical risks and/or regulatory non-compliance.
Legal advisory for the operation of Healthcare Service Providers, Pharmaceutical Managers, and Logistics Operators.
Advisory, defense, and support in strategies for communication, advertising, promotion, and commercialization of health technologies.
Advisory on structuring public and private healthcare infrastructure projects (PPP).

Litigation and Insolvency

Advisory, support in Strategic Litigation, and representation in judicial proceedings (civil, administrative, and constitutional), as well as in international commercial arbitration and investment protection arbitration.
Support in processes of recovery and pre-judicial enforcement of accounts receivable.
Advisory and representation in pre-legal collection proceedings, initiation and handling of enforcement proceedings, insolvency processes, and intervention proceedings.
Advisory on alternative dispute resolution mechanisms, such as mediation, conciliation, negotiation, settlements, and amicable composition.
Advisory on medical or manufacturer liability.
Local securities issuances, including public and private placements of shares, public and private debt bonds, structured notes, and subordinated notes.

Intellectual property

Advisory on drafting patent applications for chemical, pharmaceutical, biological products, and industrial processes.
Advisory on “copycats,” that is, issues related to voluntary and planned imitations – for example, category leader follow-up – imitation of the “look and feel” of a product’s commercial presentation.

Innovation, Technology and Personal Data

Advisory on regulatory compliance for the processing of sensitive data (collection, storage, transmission, and access) and medical records, as well as on the design of corporate strategies focused on enhanced data protection, audits, and security incident management.

Transactional