Mission
Statement




                   CITEC ING
                   AIMS TO BECOME
            THE LEADING FULL
            INTEGRATED FIRM
            TO SERVICE THE PHARMACEUTICAL INDUSTRY IN LATIN AMERICA”
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.
History



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

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

          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.
Our
Services


           QUALIFICATION & VALIDATION

           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
Specification of required users                 Commisioning
Specification of design (DS)                    Proof of acceptance in factory and fabric (PAF/PAS)
Specification of functionality (FS)             Qualification of instalation (IQ)
Risk Analysis (RA)                              Qualification of operation (OQ)
Proof of acceptance in the factory (FAT)        Qualification of performance (PQ)
Proof of acceptance on site (SAT)               Re qualification/Re validation




                Validation
               Validation of the process
               Validation of cleansing
               Validation of thermic fabric
               Validation of frozen chain
               Validation of computer systems
SOME OF OUR CLIENTS
PROJECT
MANAGEMENT
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.


Our model is based on the PMBOK of Project Management
Institute (PMI)
PROPRIETY MANAGEMENT
MODEL FOR VALIDATION




                     LEADERSHIP
        STAFF       & CHARACTER




       TECHNOLOGY    SPECIAL
                    PROJECTS
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.
STAFF   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.
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.
 SPECIAL
PROJECTS   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.
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.
TECHNOLOGY
             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.
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-
 LEADERSHIP   ects that we acquire.
& CHARACTER   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.
SOME OF OUR CLIENTS




         Vetmedica
STABILITY
STABILITY

CITEC ING offers to different industries:

     °   Accomodation of their products with climatized cham-
         bers in the following conditions:
               › Temperature
               › Humidity
              ›   Light

     °   For the amount of time that require the studies.

     °   Contingency policies

ICH / NOM – 073

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


Diversity of conditions
    1 chamber= 1 condition
    CITEC ING = Various conditions
SOME OF OUR CLIENTS
TRAINING
TRAINING

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


Some of our courses:

  °   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
SOME OF OUR CLIENTS
DEVELOPMENT & VALIDATION
OF ANALYTICAL METHODS
SERVICES

We develope analitical methods in the clients premisis


We validate analitical methods in the clients premisis


We develope protocols and reports of validation for analitical
methods


We advise on validation of analitical methods


We train in development and validation of analitical methods
DEVELOPMENT                                  PERSONAL TRAINING
OF ANALITICAL METHODS




                        VALIDATION OF
                        ANALITICAL 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
Contact us   OFFICES METROPOLITAN AREA, MÉXICO
             Ignacio Zaragoza No. 2,
             Col. EL Mirador. Tlalnepantla,
             Edo. de México.

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

             www.citec.com.mx




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

             Tels:	 01(33) 89 95 16 59

             www.citec.com.mx
CITEC ING - Presentacion Corporativa

CITEC ING - Presentacion Corporativa

  • 2.
    Mission Statement CITEC ING AIMS TO BECOME THE LEADING FULL INTEGRATED FIRM TO SERVICE THE PHARMACEUTICAL INDUSTRY IN LATIN AMERICA”
  • 3.
    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.
  • 4.
    History CITEC ING was formed in 2003 to provide support to the Health Services industry. We have consolidated our path as the leader in equipment, area qualification, process validation, project management and leasing space drug stability. 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.
  • 5.
    Our Services QUALIFICATION & VALIDATION PROJECT MANAGMENT STABILITY TRAINING DEVELOPMENT & VALIDATION OF ANALYTICAL METHODS
  • 6.
  • 7.
    QUALIFICATION & VALIDATION Robustevidence 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.
  • 8.
    LIFE CYCLE Pre requisites Qualification Specification of required users Commisioning Specification of design (DS) Proof of acceptance in factory and fabric (PAF/PAS) Specification of functionality (FS) Qualification of instalation (IQ) Risk Analysis (RA) Qualification of operation (OQ) Proof of acceptance in the factory (FAT) Qualification of performance (PQ) Proof of acceptance on site (SAT) Re qualification/Re validation Validation Validation of the process Validation of cleansing Validation of thermic fabric Validation of frozen chain Validation of computer systems
  • 9.
    SOME OF OURCLIENTS
  • 10.
  • 11.
    PROJECT MANAGMENT The teamof 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. Our model is based on the PMBOK of Project Management Institute (PMI)
  • 12.
    PROPRIETY MANAGEMENT MODEL FORVALIDATION LEADERSHIP STAFF & CHARACTER TECHNOLOGY SPECIAL PROJECTS
  • 13.
    Our staff isqualified to provide the services and handle the products of CITEC ING. Each individual is highly motivated with a mentality to fulfill our clients’ needs. STAFF 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.
  • 14.
    Through the useof 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. SPECIAL PROJECTS 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.
  • 15.
    CITEC ING understandstheir 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. TECHNOLOGY 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.
  • 16.
    CITEC ING hasdeveloped a proprietory management system for its projects in order to achieve its objective efficiently. This innovative management system ensures quality for the proj- LEADERSHIP ects that we acquire. & CHARACTER 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.
  • 17.
    SOME OF OURCLIENTS Vetmedica
  • 18.
  • 19.
    STABILITY CITEC ING offersto different industries: ° Accomodation of their products with climatized cham- bers in the following conditions: › Temperature › Humidity › Light ° For the amount of time that require the studies. ° Contingency policies ICH / NOM – 073 ° It is a requisite the realization of stability of the medi- cines that commercialize in the country
  • 20.
    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
  • 21.
    BENEFITS Maximize resource materialsand 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 Diversity of conditions 1 chamber= 1 condition CITEC ING = Various conditions
  • 22.
    SOME OF OURCLIENTS
  • 23.
  • 24.
    TRAINING The staff thatdoes our courses have an extensive background, not only as trainers but also in the industry Some of our courses: ° 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
  • 25.
    SOME OF OURCLIENTS
  • 26.
    DEVELOPMENT & VALIDATION OFANALYTICAL METHODS
  • 27.
    SERVICES We develope analiticalmethods in the clients premisis We validate analitical methods in the clients premisis We develope protocols and reports of validation for analitical methods We advise on validation of analitical methods We train in development and validation of analitical methods
  • 28.
    DEVELOPMENT PERSONAL TRAINING OF ANALITICAL METHODS VALIDATION OF ANALITICAL METHODS
  • 29.
    DEVELOPMENT OF ANALITICALMETHODS 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
  • 30.
    VALIDATION OF ANALTICALMETHODS 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
  • 31.
  • 32.
    SOME OF OURCLIENTS
  • 33.
    Contact us OFFICES METROPOLITAN AREA, MÉXICO Ignacio Zaragoza No. 2, Col. EL Mirador. Tlalnepantla, Edo. de México. Tels: +52 (55) 53 62 61 41 +52 (55) 53 61 03 12 www.citec.com.mx OFFICES GUADALAJARA Av. México No. 2798 , 5° Piso B Oficina: No 2 Col. Arcos de Vallarta, C.P 44680 Guadalajara Jalisco. Tels: 01(33) 89 95 16 59 www.citec.com.mx