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LATINO AMERICA
CONSULTORES
REFERENCE LIST
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]
Doc. Code: LAC_REF_2014 Version 5.0. Period: 2014, June
Doc. Title: Latino America Consultores Company Profile
LAC_Refecrence List_2014_5 0_eng Pagina 2 di 13
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
Doc. Code: LAC_REF_2014 Version 5.0. Period: 2014, June
Doc. Title: Latino America Consultores Company Profile
Contents
1. Latino America Consultores – Main References 4
1.1. South America References 4
1.2. Cooperation in European Project 5
1.3. Middle East – Nord Africa 5
1.4. Events, Technical Seminars & Public Conferences 6
2. Process & Quality Services 8
2.1. Regulatory Affairs 8
2.2. Quality Assurance Process Qualification & GxP Support 9
2.3. Business Development Support & International Regulatory Support 10
3. Engineering & Validation 11
3.1. Engineering - Oral Solid Dosage Forms 12
Doc. Code: LAC_REF_2014 Version 5.0. Period: 2014, June
Doc. Title: Latino America Consultores Company Profile
1. Latino America Consultores – Main References
1.1. 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
Doc. Code: LAC_REF_2014 Version 5.0. Period: 2014, June
Doc. Title: Latino America Consultores Company Profile
1.2. 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
1.3. Middle East – Nord Africa
Medis(Tunisia)
Remede Pharma (Algeria)
Hungary
Italy
Portugal
Spain
Doc. Code: LAC_REF_2014 Version 5.0. Period: 2014, June
Doc. Title: Latino America Consultores Company Profile
1.4. 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
Doc. Code: LAC_REF_2014 Version 5.0. Period: 2014, June
Doc. Title: Latino America Consultores Company Profile
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
Doc. Code: LAC_REF_2014 Version 5.0. Period: 2014, June
Doc. Title: Latino America Consultores Company Profile
2. 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
2.1. 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)
Doc. Code: LAC_REF_2014 Version 5.0. Period: 2014, June
Doc. Title: Latino America Consultores Company Profile
GMP Consultancy
International Regulatory Affairs and GMP Trends training.
GMP Consultancy
Registration of a new laboratory in Argentina and transference of BMS products to Mead Johnson.
International Regulatory Affairs and GMP Trends training.
2.2. 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)
Doc. Code: LAC_REF_2014 Version 5.0. Period: 2014, June
Doc. Title: Latino America Consultores Company Profile
2.3. Business Development Support & International Regulatory Support
Training
Business Development Activities
International Regulatory Affairs
Extended GMP Consulting Activities
Business Development Support
Business Development Activities
Partner Identification
Alliance Management
Business Development Activities
International Regulatory Affairs
Business Development Activities
Partner Identification
Alliance Management
Business Development Activities
International Regulatory Affairs
Finadiet
(Buenos Aires)
Holliday Scott
(Buenos Aires)
Kilab (Buenos
Aires)
LKM
(Buenos Aires)
Mead Johnson
(Buenos Aires)
Microsules (Buenos
Aires)
Doc. Code: LAC_REF_2014 Version 5.0. Period: 2014, June
Doc. Title: Latino America Consultores Company Profile
3. 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
Doc. Code: LAC_REF_2014 Version 5.0. Period: 2014, June
Doc. Title: Latino America Consultores Company Profile
3.1. Engineering - Oral Solid Dosage Forms
GMP Consultancy
Supporting Conceptual Analysis for new Plant Project
Engineering & GMP Support
Validation Master Plan Preparation
Conceptual & Feasibility Design
Engineering & GMP Support
GMP Plant Assessment
Supporting Equipment and System Validation
Supporting Plant Engineering and refurbishing Activity
Support Various Plant Refurbishing Plans
Engineering & GMP Support
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
Doc. Code: LAC_REF_2014 Version 5.0. Period: 2014, June
Doc. Title: Latino America Consultores Company Profile
Engineering, Qualification & GMP Support
GMP Consultancy
Software validation
Purified Water System Validation
Regulatory Affair Support
Cleaning Validation Support
Engineering, Qualification & GMP 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
