OUR SERVICES
Specialized Services
Comprehensive solutions in regulatory consulting, industrial property and the general counsel for the pharmaceutical sector and health in Colombia
WHAT WE DO
Areas of Practice
Comprehensive solutions for the pharmaceutical industry and regulatory colombian
Regulatory Affairs, Healthcare
Consulting and legal representation before the INVIMA for health records, certifications and authorizations.
Industrial Property
Registration of trademarks, patents, and trade names to the SIC and international agencies.
Certificate CCITE
Management of certificates to the Ministry of Justice for the handling of controlled substances.
Strategic Consulting
Comprehensive advice for the entry and stay of products in the colombian market.
MAIN SERVICE
Regulatory Affairs, Healthcare
We provide consultancy and legal representation integral to the INVIMA (Instituto Nacional de vigilancia de medicamentos y Alimentos). Our team has more than 30 years of experience in the management of procedures, regulatory for drugs, medical devices, cosmetics, foods, and other products of the health sector.
- Health records of medications
- Certification BPM
- Modifications and renewals
- Penal proceedings
- Export and import
INDUSTRIAL PROPERTY
Trademarks, Patents and Trade Names
We offer expert advice on asset protection of industrial property before the Superintendence of Industry and Commerce (SIC). We manage the registry, defense, and surveillance of patent, trademark and trade names for companies from the pharmaceutical sector and health.
- Trademark registration
- Obtaining a patent
- Trade names
- Oppositions and processes
- Council of State
CERTIFICATE CCITE
Chemical substances and Products Controlled
We manage the acquisition and renewal of the Certificate of Lack of Reports on the Trafficking of Narcotic drugs (CCITE) to the Ministry of Law and Justice. We advise companies that handle chemical substances and products controlled in compliance with current regulations.
- Obtaining a certificate CCITE
- Renewals and modifications
- Precursor substances
- Audits and compliance
- Representation before the Ministry of Justice
STRATEGIC CONSULTING
Comprehensive advisory for the Health Sector
We provide strategic advice, comprehensive for the entry, permanence and expansion of products and companies in the colombian market health. Our approach combines the knowledge of regulatory with the strategic vision of business to maximize opportunities.
- Strategy of market entry
- Analysis regulatory feasibility
- Due diligence regulatory
- Education and training
- Accompaniment continuous
LEGAL SERVICES
Expert Legal Advice
We have a legal team specialized in pharmaceutical law and regulation. We provide legal representation before government agencies, assistance in administrative processes and sancionatorios, and advising on compliance regulations for the health sector.
- Representation before INVIMA
- Administrative processes
- Pharmaceutical law
- Compliance regulatory
COMPLIANCE AND QUALITY
Regulatory compliance and Quality Assurance
We advise companies in the health sector in compliance with Good Manufacturing Practices (gmp), quality management systems, and post marketing surveillance. Our team accompanies you throughout the process of quality assurance and certification before the INVIMA, and regulatory bodies, ensuring the regulatory compliance of integral.
- Audits of pharmaceutical quality
- Quality management systems
- Compliance with Good Manufacturing Practices (gmp)
- Post marketing surveillance
- Improvement plans and corrective actions
LEGAL SERVICES
Management of Property and the Collection of Portfolio
We provide specialized legal services in property management and collection of portfolio companies from the pharmaceutical sector and health. Our legal experience allows for an efficient management of assets, portfolio recovery and representation in executive processes, protecting the property interests of our clients.
- Collection of portfolio reference for a preliminary ruling and judicial
- Property management real estate
- Executive processes
- Legal representation in litigation
- Negotiating payment agreements
WHY CHOOSE US?
Our Advantages
Double Expertise
We combine knowledge in Pharmaceutical Chemistry and the Right to a comprehensive approach is unique in Colombia.
+30 Years
Three decades of experience in the sector and regulatory pharmacist colombian.
Accompaniment
Custom tracking and continuous in each process to its successful resolution.
Do you need advice on regulatory or legal?
Contact us for a free initial consultation about your specific case
