Pharmaceutical Products

We advise on the formalities for sanitary registration and permits related to products such as:

Antibiotics, endocrine products, vitamins and minerals, diuretics, drugs for: digestive, nervous, respiratory, urinary and circulatory system. Diagnostic products, biological, vaccines, antitoxins, toxoids, immunotherapy, natural products and much more.

 

Legal Requirements*

• Sanitary registration : from the representative company and from the importer
• Power of Attorney (POA) of distribution, to the company that will represent the products in the country, notarized
• Certificate of free sale, issued  by the health authority in the country of origin, notarized
• Professional Representation and sponsorship Power of Attorney (POA) to the pharmacist, to represent the products technically to the authorities. Notarized.
• Certificate of good manufacturing practice, of the Manufacturer, issued by the health authority and notarized.

*(Indicative only)

 

Chemical-Pharmaceutical Requirements for pharmaceuticals and/or natural specialties *

• Presentations, FEATURES AND PACKAGING MATERIALS.
• SAMPLES:
  1. nown product: 6 pharmaceutical samples
  2. New product types A and B: depending on presentation, all in their original containers as for retail, in the same batch or lot and with 95% of remaining useful life.

• ANALYTICAL PATTERN: enough active ingredients to be used as a reference standard, with its respective analytical certificate made ​​by Quality Control Department and from the same batch used in manufacturing.
• METHOD OF MANUFACTURE, description of the process steps.
• Qualitative and quantitative formula, developed in percentage and of the dosage unit.
• PHYSICAL AND CHEMICAL FEATURES of the active principle. Structure, organic and description of formula, monograph of the excipients: summary of characteristics or monograph.
• CERTIFICATE OF ANALYSIS OF ACTIVE PRINCIPLE, issued by the manufacturer of the active principle.
• CERTIFICATE OF ANALYSIS OF FINISHED PRODUCT, issued by the manufacturer of the batch or lot to which the samples belong. Signed by the head coach of the manufacturing laboratory.
• STABILITY STUDY performed on the finished and packed product in the same way as it is sold to the public. According to standard.
• VALIDITY PERIOD AND PRODUCT STORAGE CONDITIONS.
• Method of Analysis for determination of the active ingredient in the finished product, made ​​by the laboratory, described long enough for its reproduction, all calculations and data.
• DISOLUTION PROTOCOL, for solid forms, with description of the method and equipment used. “q” value. Results.
• SUMMING EXPOSURE: scientific explanation of the reasons for which the product is a pharmaceutical specialty and justification for the inclusion of each active ingredient. Mechanism of action.
• INDICATIONS, DOSAGE AND USE.
• WARNINGS, PRECAUTIONS, Undesirable Reactions and Interactions (IF APPLICABLE).

*(Indicative only)

 

Preclinical-clinical Requirements *

• PRE-CLINICAL, TOXICOLOGICAL AND PHARMACOLOGICAL STUDIES.
• CLINICAL STUDIES.

This information should be sent, each point separately and on manufacturer lab logo identified paper sheet. For product registration, the requirements will be adjusted by type.

*(only for new products)