Medicines, health products
and food supplements
SERVICES
The services we offer for medicinal products for human use (innovative, generics/biosimilar, OTC and line extensions), veterinary medicinal products, medical devices and food complements/functional food are as follows:
Regulatory Intelligence.
Regulatory Strategy
In the initial development steps, during the registration process and in the maintenance of marketing authorisations.
Right First Time Oriented Activities:
Pre-assessment of documentation, preparation of reports and correction of potential deficiencies found prior to the application for the marketing authorisation//variation in the Regulatory Agencies
Regulatory Due Diligence/Regulatory Audit
of products and complete portfolios in purchase/sales actions between companies
Regulatory Compliance/Gap Analysis
and adequacy of non-UE product dossiers (Latin America, FDA, etc.) to UE regulations
Assistance and preparation of Scientific Advice with Health Authorities
.
Advisory services and development of IMPDs
.
Advisory services and development of ASMFs (DMFs) and documentation for CEP applications at EDQM
..
Advisory services and development of dossiers for registration of medicinal products (CTD-NeeS)
(CTD-NeeS).
Typification, presentation strategy, documentary advice and preparation of variations
(IA, IB y II).
Strategy and development of Prospect Readability Tests and Bridging Reports.
.
Specialised technical and scientific reports
.
Expert Reports for the Defense of Intellectual Property.
.
Expert reports (QOS)
.
Revisión de elementos de información del medicamento
(conditioning materials, technical sheet and leaflet).
Advisory services in the development of documentation related to Food Complements/Functional Food and their related activities (review of materials, market entry communications, inscription in the Health Food Registry, etc.)
(review of materials, marketing communications, registration in the Food Health Registry, etc.)
Other advisory and regulatory strategy activities
Consult
Direct and inverse translation (English-Spanish and Spanish-English) of scientific and regulatory documentation
of scientific and regulatory documentation.
All services offered can be contracted as individual projects, although we also offer a Comprehensive Consulting Service, renewed semi-annually, which includes many of these activities on an unlimited basis for a fixed monthly fee.
Regulatory Agencies
-
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
-
Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)
-
Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
-
Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)
-
Agencia Española de Seguridad Alimentaria y Nutrición (AESAN)