We advise companies in the pharmaceutical, biotechnological, agrochemical, food and beverages, cosmetics and medical devices sectors in meeting their business objectives aligned with the local and international regulatory framework.
OUR SERVICES:
Representation in processes and procedures before the competent Colombian health authorities and other governmental entities
Approval process for marketing authorizations
Specialized consulting on regulatory affairs and compliance
Specialized consulting and audits in certifications (e.g., GMP and CCAA)
Maquila and distribution contracts of products subject to sanitary regulation
Contracts and advice on protocols for clinical studies
Consulting on test data protection for pharmaceuticals and agrochemicals
Training in compliance with health regulations
Consulting and representation in sanction processes before administrative authorities
Consulting on access permits to genetic resources
Obtaining of toxicological opinions before the INS