T&E - Analítica


About T&E Analítica


Company created in 1999 genuinely national, based in Campinas-SP - Brazil. It does not belong to any industrial group or franchise, so your company has absolute secrecy when depositing your work. We are in an area of 8600sqm, being 3000sqm of laboratories and 800sqm of clinic. Our professionals are technicians, graduates and post graduates, in different areas, such as pharmacy, chemistry, biomedicine, biology, administration, medicine, nursing, human resources, computing and never forgetting those who maintain the structure of T&E. Today, the T&E Analítica operates 90% in the pharmaceutical and related areas and 10% in support of other areas that use the same material and human resources. We work "in vitro" and "in vivo", in the pharmaceutical area we mainly work in Bioequivalence, Equivalence, Bioisemption, Control, Sprays-Inhalers Specialists, as an example of our techniques: Microbiology, CFG, GC-GCMS, HPLC, LC-MSMS , IVFT, UVVis, Selective Electrodes-Potentiometry-Complexiometry, Karl Fischer Titulometric

and Coulometric, Osmometry, Electronic Density, Dissolution-PDCs, Electronic Density, Dissolution-PDCs, Physical-Chemical, Metals (ICPs-AA-FC), Elementary Analysis, Dossiers Dissolution, Impurities Degradation, Polymorphism, Skin Permeation, Extractable and Leachable, Interactions IFA / Excipient, Thermal Analysis, Mycotoxins, Contaminants of corks, wood-Wines and Beverages, Paper Odor, Inhalers- ACI, NGI, MSLI, DUSA, Statistics among other dozens of solutions for your company. Our goal is to support companies and industries in analytical expertise. We are national reference considered the largest laboratory in quantity of analytical techniques which provides greater possibility of solution and or better direction (read more: services). We are partners of national universities and international institutes. Partnering with T&E Analítica is talking to experts. Come visit Us and know our structures, our teams and physical space.

Services

Pharmaceutical Equivalence
Pharmaceutical Equivalence
Pharmaceutical Bio Exemption
Pharmaceutical Bio Exemption
Analytical Development and Validation
Development and Validation
Dissolution Dossier
Dissolution Dossier
Extractable and Leachable & Sorrow
Extractable and Leachable & Sorrow
Characterization of Analytical Patterns
Characterization of Analytical Patterns
Dissolution Profiles
Dissolution Profiles
Impurities of Degradation
Impurities of Degradation
Cleaning Validation
Cleaning Validation
Polymorphism
Polymorphism
Veterinary and Cosmetics
Veterinary and Cosmetics
Analysis for the Mapa
Analysis for the Mapa

Quality Assurance

QUALITY POLICY


T&E Analytica has defined a quality policy based on the following principles:

- Search for customer satisfaction, employees and suppliers, maintaining the quality of our services and competitive prices.

- To seek the market leadership in which it operates with analytical reliability.

- Train and develop employees in search of the best quality.

- Maintain communication with customers to ensure a partnership in quality standards.


All the activities developed by the laboratory follow the principles of its quality policy and comply with current regulatory standards.


Quality Assurance Unit Policy

The Quality Assurance Unit is disconnected from the technical and administrative sectors and its system monitoring activities are not under pressure from the production system. This implies that the Quality Assurance Unit has the autonomy to conduct the monitoring of the analytical activities of the laboratory with total impartiality and to report its results and observations to the top management, take corrective and preventive actions and carry out critical analyzes for continuous improvement and improvement of the Quality System. Quality management.


Mission

To seek the satisfaction of customers and employees, maintaining the quality of our services, deadlines and competitive prices.

View

Seek the market leadership in which we operate, with analytical reliability.

Values

Maintain communication with customers to ensure a partnership in quality standards. Train and develop employees in search of better quality.


QUALITY SYSTEM


The senior management of the Analytical T&E Laboratory, represented by the Director, Technical Managers and Quality Manager, establishes and assumes the commitment in the adoption and implementation of a Management System backed by the requirements of NBR ISO / IEC 17025 and NIT DICLA 035 standards for the guarantee the quality of their services.

The Quality Assurance System in the Analytical T&E Laboratory is implemented and implemented in accordance with the standards and procedures criteria:

ABNT - Brazilian Association of Technical Standards - NBR ISO IEC 17025: 2005
– General Requirements for Testing and Calibration Laboratory Competencies.

INMETRO - NIT DICLA 035
– Criteria for Accreditation of Testing Laboratories according to the GLP Principles - Good Laboratory Practices, and complementary documents.

ANVISA - Procedure GGLAS 02/17025
– Qualification of Analytical Laboratories in Health according to the Requirements of ISO / IEC 17025.

ANVISA - Procedure CGLAS 02 / BPL
– Criteria for Qualification of Laboratories according to the Principles of Good Laboratory Practice (GLP).

Complementary narrative documents:

T & E Analytics complies with Good Manufacturing Practices (GMP) with respect to the following requirements:

-Chapter 1 - Quality Assurance

-Chapter 4 - Qualification and Validation

-Chapter 5 - Complaints

-Chapter 7 - Contracts with analytical laboratories

-Chapter 8 - Self-inspection (quality audit)

-Chapter 9 - Personnel

-Chapter 10 - Training

-Chapter 11 - Personal Hygiene

-Chapter 12 - Facilities

-Chapter 13 - Equipment

-Chapter 15 - Documents

-Chapter 17 - Good Quality Control Practices

These requirements are described in a standard adapted to the scope of T&E Analytical in ISO 17025: 2005, "Requirements for Testing and Calibration Laboratories", and these practices are in harmony with what is recommended in the standards of good laboratory practice and the requirements for accreditation.


These standards base their activities that are: Conduct physical-chemical, microbiological analyzes, develop and validate methodologies and provide consulting in the areas of organic and inorganic chemistry.

T&E Analytical is accredited by CGCRE / INMETRO in accordance with ISO / IEC 17025, CRL 0461, for physical-chemical and microbiological tests on medicines, cosmetics and the environment.


Check out our scope: SCOPE OF ACCREDITATION


We are authorized by Anvisa by the Brazilian Network of Analytical Laboratories in Health (REBLAS), Reblas 006, according to RE 3,174 of July 25, 2012, according to the scope accredited by Inmetro. Click here for more details.


Qualification Reblas for Pharmaceutical Equivalence Studies - EQFAR 025 and Bioavailability / Bioequivalence, acting in the 3 clinical, analytical and statistical stages.


Accreditation with the Ministry of Agriculture - MAPA, in the Animal and Plant divisions, being:

MAPA Animal: Quality Control of Veterinary Pharmaceutical Products

Vegetable MAP: Analyzes for Fertilizers, Corrective and Inoculants


Come visit us !

Contact

Phone

Phone: +55 (19) 3756 - 6600
Fax: +55 (19) 3296 - 0128

Address

Street Lauro Vannucci, 1260
City Campinas - State São Paulo
ZipCode 13087-548

Contact US

Office Hours

  • Monday to Friday: 7:50AM to 5:38PM

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WhatsApp

  • + 55 ( 19 ) 9 9942 - 7437






© T&E Analítica