Bioequivalence

We count on the best professional staff and an extensive experience in the production of a large number of clinical studies to demonstrate bioequivalence of a drug product:
Feasibility Analysis: Of studies in or outside Chile.

Presentation of studies: Starting Protocols and Studies as such (results).

Studies: Under a strategic alliance between Austral Investments (Tecnilex) and CITCO Chile, the latter a company with extensive presence and experience in the Indian market and Chile, has been obtained the exclusive representation of AZIDUS Bioequivalence Center, recognized by ordinary office No. 1058 of May 24, 2011 issued by the Public Health Institute in favor of CITCO Chile.
Azidus has conducted and presented a large number of studies for major national laboratories.
AZIDUS has developed great experience, allowing the standardization of most of their processes, thereby resulting in accurate projection of time and costs, without contingencies or uncertainties.

Global Business Vision

This is a product that offers key technical and commercial information for the development of your business in Chile:

Market

  • Total and segmented values (public - private).
  • Values and product distribution (original brand - generic - alternative brand)
  • Distribution and Retail Channels, segmentation and values

Demand

We have gathererd complete and detailed information for your molecules:

  • Demand estimation through patient flow (epidemiological data and access to health systems)
  • Demand estimation through IMS
  • Demand estimation of public area market (values, units, buyers, competitors, purchase type, Projected income to GES)
  • Estimation clinical demand (values, units, clinics).

Analysis of strengths and weaknesses

  • External Scenarios: Opportunities and threats
  • Internal Diagnostic: Strengths and weaknesses
 

Legal Assistance

Submission and processing of applications, actions, resources and efforts before the health authority, especially regarding the exercise of individual rights in relation to the actions of public authorities contained in the new law on administrative procedures.

Sponsorship, representation and defense in health summaries, until completely processed, exercising all the appropriate actions.

Public Tenders, Resolutions issued by the authority:
Sponsorship and representation in legal actions at the administrative and judicial headquarters, against actions that may be challenged for being considered arbitrary, contrary to law or discriminatory.

Constant monitoring of the processing status of the initiatives, requests, petitions and actions that may be formulated.

Implementation of the right of petition in relation to the principle of public and administrative transparency, ie to have access to information and to know the status of completion of the procedures in which there is interest.

Application of the right to raise claims at any stage of the administrative procedure.
The resolutions and administrative audits: Legal value and resources that come against in order to negate their effects.

All the reform projects both regulatory and legal related to the health area.

Sanitary Registers

Sanitary registration is a commercialization authorization for pharmaceuticals, cosmetics, medical devices or food, issued by the Chilean government through the Public Health Institute (Instituto de Salud Publica - www.ispch.cl).

We process your need for New Pharmaceutical Product Registration, Similar, Phytodrug or Cosmetic,  in well defined and agreed times;  we can ENSURE THE COMPLIANCE OF DEADLINES in both our management and the public instance.

We are specialists in high complexity registrations and count on our staff professionals who know most of sanitary registration in Chile, all with a wide and proven experience in both the private and public areas. We have over 500 approved registrations and an extensive portfolio of important clients, both in Chile and abroad.

Don’t waste your time while getting your representative or getting installed in Chile, Tecnilex generates the appropriate legal tools so YOU MAY HAVE YOUR REGISTERS AT YOUR DISPOSAL EVEN WITHOUT BEING IN CHILE, and then transfer it to whomever you like.

  • High complexity registrations (Biological recombinant vaccines, etc.)
  • Registrations +Manufacturing validation process + Bioequivalence of origin ( from sanitary agency type IV)
  • Registrations +Manufacturing validation process + Bioequivalence of origin ( from other sanitary agency )
  • Innovative pharmaceutical registrations (or ordinary procedure)
  • Simplified procedure registrations

Commercial Regulatory Intelligence (CRI)

Commercial Regulatory Intelligence is a Tecnilex's exclusive product, and can be described as a set of proceses, with the aim to identifying, extracting and transforming different atributes into diferentiating elements for your products. This allows to potentiate strengths and to minimize weaknesses, all related with the licitation's requirements and with supporting promotional resources.

Therefore, this is about to give technical attributes of the product to its commercial body, that it usually is only knowledge for experts, but all of this embeded in the bidding proceses, trough a technical, juridic and administrative strategy.

That was mentioned before involve an agressive and detailed analysis of the product, its competence, and strategy development for participating and impugning in different biddings, by a very specific juridic mechanism, to finally build a POTENT and AGRESSIVE position against the competitors.