Services

Activities


  • Registration of producers according to the area in which will serve the company in question. (Aircraft)
  • Product Registration: Register
  • Registration Register your product modifications.
  • Relations with Health Authorities involved in the specific task to perform.
  • Advice on the best strategy for product registration.
  • Track every case brought to completion.
  • Tercerismo: Preparation of documentation for the application for intervenors: local or international companies as determined.


  • Subsequent comprehensive counseling involves: maintaining the record of each product, the import activities, which the type of product requires health authority and its release for marketing in the Argentine market. (Importing authorization issued by INAME, INAL and Medical Technology).
  • Preparation of the technical dossier for registration (processing methods, quality control, stability, bioequivalence when applicable).
  • Preparation and standardization of Standard Operating Procedures for each activity carried out by GMP standards.

Work Methodology


Preparation of technical documents

Preparation of documents for registration under regulations ANMAT INAME WIRELESS: Task performed by a professional pharmacist in direct combination with the Technical Director of the contracting company, in order to reliably meet the legal requirements for each type of process and establishing clear guidelines for carrying out the work.

Administrative agencies

Management to follow ANMAT, INAME and WIRELESS.; Task being performed with the daily presence in the various departments, and active administrative monitoring records.

Professional Solicitors

The case that comes to the instance of the assessment by a professional representative of the health authority, is undertaken by the / Pharmaceutical Professionals / s belonging to this company, who / who will try, with the corresponding evaluator for the provision of information requests the process or negotiate or receive instructions on incorporating additional information that the assessor requests.

Companies third

Was hired as needed and will be in charge of the Director of the group, who will contact you and the person.

Objectives of the research methodology


Professionalism

Treatment according to the most advanced tracking communication techniques (NLP), and the experience offered by this company.

Time

Ensure that the file accordingly ANMAT exit in the shortest time possible. This depends largely on how to address the procedure for each particular case, according to the best strategy for each procedure (be agreed between the Technical Director of the contracting company and pharmaceutical professional in this business).

Privacy

Absolute.