Mission Statement

TO SERVICE THE PHARMACEUTICAL INDUSTRY IN LATIN AMERICA”

CITEC INGAIMS TO BECOME

THE LEADING FULLINTEGRATED FIRM

Overview

CITEC ING is a Mexico City based firm that provides special-ized services to the pharmaceutical, chemical, cosmetic and hospital industries.

The company is comprised of five business units to provide these services efficiently to their clients.

Through experience, technology, efficiency, qualified staff and teamwork, CITEC ING has been able to create strong relations with its clients from the services that it provides.

Along with these positive attributes, CITEC ING received a cap-ital commitment in 2012 from Beamonte Investments, a firm that is based in Boston, Massachusetts. It is one of the leading investment firms in the world and has allowed CITEC ING to grow exponentially since their partnership.

We have consolidated our path as the leader in equipment, area qualification, process validation, project management and leasing space drug stability.

CITEC ING was formed in 2003 to provide support to the Health Services industry.

In 2011 we were looking to innovate through technology and therefore created a strategic alliance with ELLAB INC, where we became the exclusive distributors of their high quality prod-ucts in Latin America.

History

QUALIFICATION & VALIDATION

Our Services

PROJECT MANAGMENT

STABILITY

TRAINING

DEVELOPMENT & VALIDATION OF ANALYTICAL METHODS

QUALIFICATION & VALIDATION

QUALIFICATION & VALIDATION

Robust evidence supports our protocols for regulatory compli-ance and auditing, which are created in order to attain a sub-stantial standard of qualification and validation for equipment and systems within the pharmaceutical industry.

We have developed a complete life cycle for each equipment and system, as this is a prerequisite to acheive considerable standards of qualification for our products and services.

LIFE CYCLE

Pre requisites Qualification

Validation

Specification of required users Commisioning

Validation of the process

Specification of functionality (FS) Qualification of instalation (IQ)

Validation of thermic fabric

Specification of design (DS) Proof of acceptance in factory and fabric (PAF/PAS)

Validation of cleansing

Risk Analysis (RA) Qualification of operation (OQ)

Validation of frozen chain

Proof of acceptance in the factory (FAT) Qualification of performance (PQ)

Validation of computer systems

Proof of acceptance on site (SAT) Re qualification/Re validation

SOME OF OUR CLIENTS

PROJECTMANAGEMENT

Our model is based on the PMBOK of Project Management Institute (PMI)

PROJECT MANAGMENT

The team of CITEC ING has been able to leverage their exper-tise to form a new approach of project management that en-sures efficiency and reliability.

Our model of services and projects of validation assures suc-cessful and timely projects, developing CITEC ING through a innovative technical and administrative path to handle our proj-ects and services.

PROPRIETY MANAGEMENT MODEL FOR VALIDATION

STAFF

SPECIAL PROJECTS

TECHNOLOGY

LEADERSHIP & CHARACTER

Our staff is qualified to provide the services and handle the products of CITEC ING. Each individual is highly motivated with a mentality to fulfill our clients’ needs.

All of our staff members have been tested by a physcometric exam and assessed in a technical interview in order to etab-lish utmost efficiency within the company. Our proeficent infra-structure also ensures productivity and teamwork.

STAFF

Through the use of several means of technology, CITEC ING is able to reach high levels of productivity from its products and services. Primarily, the use of protocols and standardized docu-mentation maintains CITEC ING’s efficiency throughout all of its operations.

Also, our use of innovative technology enable us to attain high standards of quality. For example, medical equipment and in-struments with traceability CENAM/NIST, electonic bibilogra-phies that are used for consulting in our projects, high resolout-ion photographic cameras, personal laptops, updated software, phonelines, radios of communication etc.

SPECIAL PROJECTS

CITEC ING understands their duty and responsibility to their cli-ents and will go the extra mile in order to fulfill their needs. We encourage effective communication with out clients in order to achieve this goal and we highly value the confidentiality and se-curity of the information that our clients trust to share with us.

Our team maintains a hardworking and motivated attitude, along with the belief in the benefits of working in a team. We are confident that our work ethic allows us to be successful in our projects and deliver to the needs of our clients.

TECHNOLOGY

CITEC ING has developed a proprietory management system for its projects in order to achieve its objective efficiently. This innovative management system ensures quality for the proj-ects that we acquire.

In order to achieve consistency we utilize a manual for our projects to standardize our services. We use a support service system that accompanies our auditing services, which also en-sures quality and productivity of our projects.

LEADERSHIP & CHARACTER

SOME OF OUR CLIENTS

Vetmedica

STABILITY

ICH / NOM – 073

STABILITY

CITEC ING offers to different industries:

Accomodation of their products with climatized cham-bers in the following conditions:

It is a requisite the realization of stability of the medi-cines that commercialize in the country

Temperature

Humidity

Light

For the amount of time that require the studies.

Contingency policies

°

°

°

°

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›

CONDICIONES DE OPERACIÓN

30 °C ± 2 °C / 35 % ± 5 % HR

40 °C ± 2 °C / 75 % ± 5 % HR

30 °C ± 2 °C / 75 % ± 5 % HR

DE 30 °C A 80 °C

BAJA TEMPERATURA, HASTA 25 °C

5 °C ± 3 °C / HA

30 °C ± 2 °C / 65 % ± 5 % HR

TEMPERATURA VARIABLE

25 °C ± 2 °C / 60 % ± 5 % HR

Diversity of conditions 1 chamber= 1 condition CITEC ING = Various conditions

BENEFITS

Maximize resource materials and huamans of each of the com-panies

Make more efficient the staff without maintenance cost

Flexibility and scalability,

Increment the capability to absorb immediate fluctuations of volume

SOME OF OUR CLIENTS

TRAINING

Validation of processes

Validation of computerized systems

Good practices of fabrication, documentation, laboratiry and storing.

Systems of quality control ISO 9001:2008

Design and application of system documentation

TRAINING

The staff that does our courses have an extensive background, not only as trainers but also in the industry

Some of our courses:

°°°

°°

SOME OF OUR CLIENTS

DEVELOPMENT & VALIDATION OF ANALYTICAL METHODS

We develope protocols and reports of validation for analitical methods

We train in development and validation of analitical methods

SERVICES

We develope analitical methods in the clients premisis

We validate analitical methods in the clients premisis

We advise on validation of analitical methods

Personal  Training  

Valida/on  of  Anali/cal  Methods  

Development  of  Anali/cal  Methods  

PERSONAL TRAININGOF ANALITICAL METHODSDEVELOPMENT

VALIDATION OFANALITICAL METHODS

DEVELOPMENT OF ANALITICAL METHODS

Development of analitical methods in the premisis of the client, while ad-justing to their time and resources

We designed a method that is permitted according to the physiciochemi-cal characteristics for the matter in determination and quanitification

VALIDATION OF ANALTICAL METHODS

Validation of analitical methods in the premisis of the client adjusting to their needs

It is the process by which the laboratory establishes the characteristics of its performance of methods. These characteristics meet the analitcial applications that have been previously identified

PRODUCTS

SOME OF OUR CLIENTS

Ignacio Zaragoza No. 2, Col. EL Mirador. Tlalnepantla, Edo. de México.

Tels: 01(33) 89 95 16 59

Tels: +52 (55) 53 62 61 41 +52 (55) 53 61 03 12

Av. México No. 2798 , 5° Piso BOficina: No 2Col. Arcos de Vallarta, C.P 44680Guadalajara Jalisco.

Contact us OFFICES METROPOLITAN AREA, MÉXICO

OFFICES GUADALAJARA

www.citec.com.mx

www.citec.com.mx