Documentation

Our Register Department prepare all the necessary technical documentation and the “Dosiers” to obtain the sanitary registrarion of each product
for any country.

The required information to apply to the sanitary registrarion vary for each country.

Some of the documents that could be necessary are:

1. Free sale certificate: declare quail-quantitative formulation , duly legalized.
2. GMP or Good Manufacturing Practices: issue by the official sanity authority, duly legalized in case of imported products.
3. Dosier:

• Proposed name.
• Layout of text of packaging materials.
• Quali-quantitative formulation, in the case that an excess of any active ingredients added, this excess addition needs to be justified.
• Monography of the product.
• Packaging material specifications.
• Manufacturing procedure: procedure description in detail, Master formula, Manufacturing Order (of an industrial batch, with corresponding signatures verifying the quantities weighed), in-process controls.
• Analytical procedure for the active ingredients and the finished product:  specifications, physicochemical characteristics, identification and assay of the active ingredient in the finished product.
• Stability studies of the finished product.
• Type of package (bulk, for sale).
• Pre-clinic studies, pharmacological ground of the expected therapeutic effect, pharmacokinetic studies, toxicology, clinical trials.
  

This are some of the necessary documentation for product registration and is diferenfent from contry to country.