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LATINO AMERICA

CONSULTORES

COMPANY PROFILE

Update 2014, June

Version 5.0

Latino America Consultores – Carlos Villate 1661 Oficinas 3 y 4 - Olivos - CP 1636 Teléfono: +54 11 4796.5510 /4795.0168 [email protected]

mailto:[email protected]

Doc. Code: LAC_REF_2014 Version 5.0. Period: 2014, June

Doc. Title: Latino America Consultores Company Profile

LAC_Company Profile_2014_5 0_eng Pagina 2 di 18

Document Control

Version Data Author Issue’s Reasons

1.0 (2013)

January, 2013 G. Rossi First review 2013

2.0 (2013)

August, 2013 G. Rossi Second Review 2013

1.0 (2014)

January, 2014 G. Rossi First review 2014

2.0 (2014)

February, 2014 G. Rossi Second Review 2014

3.0 (2014)

March, 2014 G. Rossi Third Review 2014

4.0 (2014)

April, 2014 G. Rossi Fourth Review 2014

5.0 (2014)

June, 2014 G. Rossi Fifth Review 2014

Version Control



Contents

1. Latino America Consultores Overview 4

1.1. Company Operation 5

1.2. Additional Services and Methodology 6

1.3. Address 6

2. Latino America Consultores – Main References 7

2.1. South America References 7

2.2. Cooperation in European Project 8

2.3. Middle East – Nord Africa 8

2.4. Events, Technical Seminars & Public Conferences 9

3. Process & Quality Services 11

3.1. Regulatory Affairs 11

3.2. Quality Assurance Process Qualification & GxP Support 12

3.3. Business Development Support & International Regulatory Support 13

4. Engineering & Validation 14

4.1. Engineering - Oral Solid Dosage Forms 15

5. Compliance IT (& Automation) 17



1. Latino America Consultores Overview

Latino America Consultores since its foundation, had worked in cooperation with International Partners, to be able to integrate the local competences with the once of the International Partners, to supply the most adequate support to all the Customer located in Center and South America.

The Cooperation with International partners, allows Latino America Consultores to provide an International State of the ART support, sharing with these partners the most recent Approach, Methodology and Technologies.

Founded in 2008, to support Customer’s Project in Both, local (ANMAT) and cGMP/EU-GMP Regulated Environment, in only 6 years of continuous activity has become one of the Regional Leading GMP Consultancy Company.

Following the market requirements evolution, for both GMP Regulatory and GMP Production Compliance, LAC could provide customer support covering the following areas:

R&D – Research & Development

Consultancy for Business Process Re-Engineering

Consulting for company (and corporate) organization, support Process change and Structure changes

Technology Transfer

Engineering (Design & Refurbishing)

Regulatory Compliance Support

Industrial Process Qualification

Supply Chain Optimisation

Quality assurance & Quality Control

Information Technology – System Integration, Infrastructure Management & Optimisation, IT Compliance

Our experts’ team, incorporates a wide range of skills, providing coverage to manage all stages of product life cycle in compliance, for Production, Quality Process and Business Development.



1.1. Company Operation

LAC - Latino America Consultores count on Team of consultant, using a standard methodology, including Process Mapping Tools, Risk Analysis Tools, reporting tools.

The LAC Staff is organised as a Group of Project Manager, who can individually control the external contractor team or the Customer’s Team/Resources.

The main expertise is focused on the following services areas:

Process & Quality

Scale Up & Technology Transfer Support

Strategic Business Support (Production Strategy, Product Portfolio Management)

Quality Assurance & GMP Process Support Auditing

Regulatory (National & International)

Process Qualification

Engineering & Validation

Feasibility & Conceptual

Design & Engineering Support

Revamping

Third party Design Qualification

Qualification support for Utilities & Plant, Support for Process Automation)

IT to Compliance

(IT & Compliance Consultancy, System Integration, Computer System Validation and GMP Compliance Infrastructure Management)

Through its own expertise LAC is able to support all needs of customers in terms of product life cycle steps, from formulation to finished products release, in compliance with international requirements.

Quality by Design & Risk Management are the bases of our internal methodology and project management behaviour.

LAC operates supporting Multinational Pharmaceutical Organisation, National & Local Pharmaceutical Company, API Producer and Contract Manufacturers.

LAC – Latino America Consultores, has its own office in Buenos Aires,

and Uruguay, covering from here, and in cooperation with partners, all the Latino American Countries; LAC can Operate in all Sur America, supported by local partner in Mexico and Brazil.



1.2. Additional Services and Methodology

LAC works with CTP since its/his beginnings in 2008, CTP can provide a network of partners in Europe supporting operations, regulatory for Licensing and Strategic Consulting. Actually CTP is involved in International projects concerning:

Internal Business Process Re-engineering (Strategic, Operation, Process Optimisation, QA/Quality Management System, GMP Review, LEAN, SWAT)

Technology Transfer Support (Internal from R&D to Production &/or between different sites)

Regulatory Support (Strategic for Product & Standard for Dossier Registration & Variations)

The internal CTP Methodology is inspired and aligned to the last requirements and Guide Line, using a Quality by Design (QbD) and Risk Based Approach from Design to Qualification (ICH-Q8, ICH – Q9 ICH-Q10, GAMP®5) CTP is an active member of many Pharmaceutical Association, such as AFI, PDA, ISPE, PLG).

1.3. Address

Latino America Consultores Carlos Villate 1661

Oficinas 3 y 4 - (1636)

Olivos - Buenos Aires - Argentina

Tel/Fax +54 11 4796.5510 / 4795.0168

Email [email protected]

Web http://www.latconsultores.com.ar

http://www.latconsultores.com.ar/



2. Latino America Consultores – Main References

2.1. South America References

Bago

BMS

ELEA

Finadiet

Gema Biotech

Holliday Scott

Inghenia

Kilab

Laboratorio Ariston

Laboratorio Casara

Laboratorio Casasco

Laboratorio Dorrego

Laboratorio Hidalgo

Laboratorio Kemex

Laboratorio Omega

Laboratorio Raymos

Laboratorios Dispert SA

LABYES

LKM

Mead Johnson

Mega Pharma

Microsules

Montpellier

OCASA

Pierre Fabre

Rovafarm

Syntex



2.2. Cooperation in European Project

Human Bioplazma KFT

Richter Gedeon (Gedeon Richter)

Teva

Abbott

Antibioticos

Astellas

Aventis

Kedrion

Janssen-Cilag

Novartis

Patheon

Recordati

Temmler

Yamanouchi

Wyeth

Zambon

Lusomedicamenta (ex. Janssen-Cilag)

Antibioticos Leon

Merck Sharp & Dohme

2.3. Middle East – Nord Africa

Medis(Tunisia)

Remede Pharma (Algeria)

Hungary

Italy

Portugal

Spain



2.4. Events, Technical Seminars & Public Conferences

For more information, please visit Latino America Consultores Web-site:

http://www.latconsultores.com.ar/novedades.asp

ETIF 2008 - Conferences:

Pharmaceutical Utilities

GAMP® 5 Overview

Risk Based EBRS Implementation using GAMP® 5

Contamination control according to Annex I

Pharmaceutical Technology - Technical Publication:

o Exporting in Europe

o Annex I EU-GMP

CILFA – Conference: European Market

Sindusfarma: Computer System Validation & GAMP® 5

Universidad de Belgrano – Conference: Computer System Validation

Gobierno de la Ciudad de Bs. As.: Conference Cycle related to:

o International Pharmaceutical Exportation Rules for Pharmaceutical Product

o European Registration

Gobierno de la Ciudad de BsAs: Supporting launch of Foreign Trade Database;

Universidad de Belgrano – Conference – Product Traceability – Overview of International On-Going Regulation & Project

Sindusfarma – Conference: Product Traceability – Overview of International On-Going Regulation & Project (Control de Autenticidad y Trazabilidad de Medicamentos)

ETIF 2010:

o Participation to the 1st “Ronda de Negocio”

o Conference: CTD and Regional Variations of CTD

o Conference: MENA and (Caspian región or east Europe) pharmaceutical markets and regulations

o Conference: International and ANVISA tracealibility requirements, en el marco del Congreso ETIF 2010

o Pharmaceutical Technology Magazine - Technical Publication: Trazabilidad de Medicamentos;

2008

2009

2010

http://www.latconsultores.com.ar/novedades.asp



ExpoFybi 2011:

o Conference: Trazabilidad de los Productos Farmacéuticos

o Conference: Available Technologies

o Participation to “Ronda de Negocio – ExpoFybi – 2011”

Sindusfarma – 2nd Workshop Conference: Product Traceability – Overview of International On-Going Regulation & Project – 2011 Updates

Gobierno de la Ciudad de Bs. As. – Conferencias:

o Aspectos Regulatorios Internacionales

o Seminario sobre Requisitos para la Exportación EMEA/FDA

ETIF 2012:

o Conference: Conferencia Validación de SAP: Su impacto en el Desarrollo del Negocio

o Participation to “Ronda de Negocios – ETIF 2012”

2011

2012

http://www.latconsultores.com.ar/upload/TrazabilidaddelosProductosFarmac%C3%A9uticos.pdf

http://www.latconsultores.com.ar/upload/2ModAvailableTechnologies.pdf



3. Process & Quality Services

This expertise may support implementation, review of Quality related issues, and related Quality System Project for daily activities, including Regulatory Services.

As a brief overview, the main QA and GMP Process services supplied are:

Auditing

Regulatory Affair

GMP and GLP Support & GMP Review

Process & Impact Assessment

Support for Technology Transfer

Managing, Reviewing and Submit Regulatory Documents (CTD, eCTD, APR, QPR, EBR)

Support for Quality Management System Implementation & Review

Support for Authorities Inspection

Supplier & Raw material Qualification

In House Training

Public Training

3.1. Regulatory Affairs

International Regulatory Affairs and GMP Trends training.

GMP Consultancy

Training

Regulatory Affairs Support

GMP Consultancy

Training

GMP Consultancy

International Regulatory Affairs training.

Introduction

Bago

Bristol Myers

Squibb

(Buenos Aires)

Laboratorios

BAGO (Buenos

Aires)

LABORATORIO CASASCO

(Buenos Aires)



GMP Consultancy


GMP Consultancy

Registration of a new laboratory in Argentina and transference of BMS products to Mead Johnson.


3.2. Quality Assurance Process Qualification & GxP Support

Risk Assessment

Assessment

Supporting Quality Management System Review and New Quality Management System Implementation

International GMP Audits and Consultancy.

European GMP Consultancy for veterinary food products

GMP Consultancy

Process Validation

GMP Consultancy

Training

GMP Consultancy

Training

Supporting Business Development

LABORATORIO

CASARA (Buenos Aires)

MEAD JOHNSON

(BMS Buenos Aires)

Laboratorios MONTPELLIER

(Buenos Aires)

ELEA

(Buenos Aires)

Laboratorio

Dorrego (Montevideo)

Laboratorio

Omega

Pierre Fabre (Buenos

Aires)

Quimica

Montpellier

(Buenos Aires)

Syntex

(Buenos Aires)



3.3. Business Development Support & International Regulatory Support

Training

Business Development Activities

International Regulatory Affairs

Extended GMP Consulting Activities

Business Development Support


Partner Identification

Alliance Management




Partner Identification

Alliance Management



Finadiet

(Buenos Aires)

Holliday Scott

(Buenos Aires)

Kilab

(Buenos Aires)

LKM

(Buenos

Aires)

Mead Johnson

(Buenos

Aires)

Microsules

(Buenos

Aires)



4. Engineering & Validation

This Expertise may support Design, Project Management, Construction, Commissioning, Qualification, Revamping & Maintenance engineering activities related to Plant and Equipment.

As a brief overview, the main topics covered are:

ENGINEERING

Basic & Conceptual Design

Value Engineering

Project Management

Start-up & Commissioning

QUALIFICATION&VALIDATION

Impact Assessment

Validation Master Plan

Design Qualification

Installation Qualification, Operational Qualification, Performances Qualification

GAP Analysis

Remediation Program Support

Calibration & Maintenance

Warehouse Environmental Monitoring

Supply Chain Control Implementation

Introduction



4.1. Engineering - Oral Solid Dosage Forms

GMP Consultancy

Supporting Conceptual Analysis for new Plant Project

Engineering & GMP Support

Validation Master Plan Preparation

Conceptual & Feasibility Design


GMP Plant Assessment

Supporting Equipment and System Validation

Supporting Plant Engineering and refurbishing Activity

Support Various Plant Refurbishing Plans


Product Strategic Analysis

Conceptual & Feasibility Study

Engineering, Qualification & GMP Support

GMP Assessment

GMP Review

Value Engineering

Qualification & Validation

GMP Consultancy

Equipment Validation

Kilab

(Buenos Aires)

LABYES

(Buenos

Aires)

Laboratorio

Ariston

(Buenos Aires)

Laboratorio

Dispert (Uruguay)

Laboratorio

Omega

Laboratorio Kemex




GMP Consultancy

Software validation

Purified Water System Validation

Regulatory Affair Support

Cleaning Validation Support


Conceptual design

Advanced Basic Design

Procurement

GMP Consultancy

Quality Management System Software Validation

Design Qualification Support for the New Plant

New QC Facilities

Conceptual Design

Cost evaluation

GMP review

URS definition

Suppliers evaluation and coordination

Project Management

Commissioning

Qualification & Validation

Laboratorio

Raymos

(Buenos

Aires)

Mead Johnson

(Buenos

Aires)

Mega Pharma (Uruguay)

Mead Johnson



5. Compliance IT (& Automation)

This expertise may support IT Project in Regulated Environment as Pharmaceutical, for both, Compliance/Validation Issues and Information Technology.

As a brief overview, the main services supplied by IT to Compliance Area are:

Feasibility Studies

URS defintion

Supplier Qualification & Support for Software Selection

GMP & System Risk Assessment

Project Management

Computer System Validation

21 CFR Part11 Compliance

Remediation Program Support

Providing GMP Compliant Solution

Trainings

Support for IT Infrastructure Management (ref.: ISO 20000, ITIL, BSI-7799)

IT Networks Qualification

Feasibility study BPCS 6.004 version validation

GMP Training

CSV Training

21CFR11 Training Session

21 CFR Part 11 DCS Assessment and Remediation Plan Definition

GMP Assessment for the shop floor control system

Automatic Machines Validation

BPCS Upgrade Validation (2004) (2007)

Totalchrome Validation (upgrade – 2002 –2004)

GMP Site Risk & Process Analysis

SCADA Validation (2007)

Plant GXP Assessment for Computerised System

Validation Master Plan for Computer System Validation

Execution of Computer System Validation and 21 CFR Compliance Project

Introduction

Abbott

AMEGA Biotech

GEMA Biotech

(Buenos Aires)



LIMS validation (2003/2004)

QC Remediation (2007)

Empower Validation (2007)

Process Automation Assessment

Risk & GAP Analysis

Remediation Plan

DCS Validation (2003/2004)

21 CFR Part 11, GAMP®5 and Computerised System validation

Training Project Assessment Supporting System’s implementation Compliance Activities Computerised System Validation Support

Training Process Assessment SAP System Functional Assessment SAP Validation

GMP Consultancy Training Project Assessment Software Validation

Wireless Warehouse System Validation (2004) Dispensing System Update Validation Support 21CFR Part 11 International Assessment Program Support SAP vers. 6.0 Porting Validation Empower Validation

Antibioticos

Antibioticos (Leon)

Laboratorio

Hidalgo (Buenos Aires)

OCASA

(Buenos

Aires)

Rovafarm

Temmler