Medicines

Available in:

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

Medicines

The firm has experts led by Pharmaceutical Chemists, Medical Epidemiologists, Pharmacologists and Toxicologists who provide support advice in relation to the sanitary regime, sanitary surveillance, Sanitary Registry, certifications and audits in GMP and GLP, in the countries where it operates.

Our advice and accompaniment contributes to pharmaceutical laboratories having a multidisciplinary team expert in current local health regulations, related to the manufacture, import and commercialization of medicines for compliance with regulatory requirements in order to carry out operations in each country.

Medicines of Biological Origin

Scientific support for the submission of applications for pharmacological evaluations of new molecules.
Feasibility analysis in comparability studies.
Medical support for the presentation of approval, for the adjustment or preparation of IPP, PSUR and PGR Inserts.ción, para el ajuste o elaboración de Insertos IPP, PSUR Y PGR.
Scientific support for the presentation of dossiers for new drugs of biological origin before the specialized committees in Colombia.
Technical and legal assessment to establish the feasibility of obtaining data protection under Decree 2085 of 2005.
Support in the technical direction of companies that do not have the service in the country.
Release of batches when required, review of labeling.
Support in the nationalization of products when there are regulatory issues.
Support in GMP certification visits made by the health authority abroad to grant guarantees to importace la autoridad sanitaria en el exterior para conceder aval para importar
Management for the presentation of requests for registration, modification, authorization and certification of changes in medicines.
Organization of technical and legal pharmacological dossier for presentation to the health agency.
Homologation of GMP certificates issued by countries abroad when feasible.
Response to processes calling for ex officio review by health agencies.
Authorization to import unavailable vital medicines, management to obtain packaging depletions
Legal support in the response and sanction processes before the health agency.

Chemical Synthesis Drugs

Scientific support for management, executive summary and presentation of application for pharmacological evaluations of new molecules, new associations, new concentrations, new pharmaceutical forms.
Management, executive summary, executive summary and presentation for the presentation of bioequivalence and bioavailability studies.
Medical support for the presentation of approval, for the adjustment or preparation of IPP, PSUR and PGR Inserts.
Technical and legal assessment to establish the feasibility of obtaining data protection under Decree 2085 of 2005.
Support in the technical direction of companies that do not have the service in the country.
Support in the nationalization of products when there are regulatory issues.
Support in GMP certification visits made by the health authority abroad to grant guarantees for imports.
Management for the presentation of requests for registration, modification, authorization and certification of changes in medicines.
Organization of technical and legal pharmacological dossier for presentation to the health agency.
Homologation of GMP certificates issued by countries abroad when feasible.
Import authorization for vital medicines not available.
Technical and legal support in contesting and sanctioning processes before the health agency, defense before health agencies in legal processes, sanctions, inspections, decision-making measures.
Apoyo técnico y legal en la contestación y procesos sancionatorios ante la agencia sanitaria, defensa ante las agencias sanitarias en procesos legales, sancionatorios, inspecciones, toma de medidas.

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

Medicines

Medicines

Medicines of Biological Origin

Chemical Synthesis Drugs

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