Phytotherapeutics - Colombia

*With our services, marketing authorizations are achieved in the countries where we operate, we provide regulatory services, we do not manufacture products

Phytotherapeutics

The firm has experts who provide advice on matters related to the sanitary regime, sanitary surveillance, Sanitary Registration and obtaining certificates of good manufacturing practices for phytotherapeutic and traditional phytotherapeutic products based on the application of Decree 2266 of 2004 regarding Legal and technical aspects such as stability, analysis and advertising authorizations of the products.

Below, you will find the services associated with Phytotherapeutics:

Scientific support for the submission of requests for pharmacological evaluations of new molecules, new associations, new concentrations, new pharmaceutical forms.
Management for the presentation of requests for registration, modification, authorization and certification of changes in Phytotherapeutic medicines
Organization of the technical and legal pharmacological dossier for submission to the health agency.
Homologation of GMP certificates issued by countries abroad when feasible
Support in GMP certification visits made by the health authority abroad to grant guarantees for imports.
Labeling review
Management to obtain packaging depletions
Response to processes for ex officio review by health agencies
Legal support in the response and sanction processes before the health agency. Defense before health agencies in legal processes, sanctions, inspections, taking measures.

Scientific support for the submission of requests for pharmacological evaluations of new molecules, new associations, new concentrations, new pharmaceutical forms.
Management for the presentation of requests for registration, modification, authorization and certification of changes in Phytotherapeutic medicines
Organization of the technical and legal pharmacological dossier for submission to the health agency.
Homologation of GMP certificates issued by countries abroad when feasible.
Support in GMP certification visits made by the health authority abroad to grant guarantees for imports.
Labeling review
Management to obtain packaging depletions
Response to processes for ex officio review by health agencies
Legal support in the response and sanction processes before the health agency. Defense before health agencies in legal processes, sanctions, inspections, taking measures.

Check with our professionals online or get frequent questions about registration processes in different countries

Phytotherapeutics - Colombia

Phytotherapeutics

COLOMBIA AND CENTRAL AMERICA

ARUNA ASESORES SAS

MEXICO

ARUNAMEX SA DE CV

PERU

ARUNA ASESORES PERU

COLOMBIA AND CENTRAL AMERICA

ARUNA ASESORES SAS

MEXICO

ARUNAMEX SC

PERU

ARUNA ASESORES PERU