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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]
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
Doc. Code: LAC_REF_2014 Version 5.0. Period: 2014, June
Doc. Title: Latino America Consultores Company Profile
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
Doc. Code: LAC_REF_2014 Version 5.0. Period: 2014, June
Doc. Title: Latino America Consultores Company Profile
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.
Doc. Code: LAC_REF_2014 Version 5.0. Period: 2014, June
Doc. Title: Latino America Consultores Company Profile
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.
Doc. Code: LAC_REF_2014 Version 5.0. Period: 2014, June
Doc. Title: Latino America Consultores Company Profile
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
Doc. Code: LAC_REF_2014 Version 5.0. Period: 2014, June
Doc. Title: Latino America Consultores Company Profile
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
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Doc. Title: Latino America Consultores Company Profile
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
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Doc. Title: Latino America Consultores Company Profile
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
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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
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Doc. Title: Latino America Consultores Company Profile
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)
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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.
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)
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Doc. Title: Latino America Consultores Company Profile
3.3. 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
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
Doc. Code: LAC_REF_2014 Version 5.0. Period: 2014, June
Doc. Title: Latino America Consultores Company Profile
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
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
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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
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Doc. Title: Latino America Consultores Company Profile
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)
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Doc. Title: Latino America Consultores Company Profile
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