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African Consultants for industries such as healthcare, pharmaceutical, medical product, biotechnology, life science, agriculture and clinical trials industries such as Egypt, Kenya, Morroco, South Africa, Zimbabwe, etc.

 

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25 Most Recent Registered Regulatory Consultants and Consulting Firms

 
25 Most Recent Registered Regulatory Consulting Firms
Advanced Medicals Consortium - Regulatory Submissions o FDA - IDE, HDE, HUD, NDA, 510(k), PMA & Combination products o EU - CE, IVDD, Design Dossier, MDD o Canadian Health Class I-IV, CMDR o Japanese Ministry of Health (MHLW)  Computer System Validation for Equipment, Processes and Products o IEEE, ISO/IEC, ISPE (GAMP4), SEI (Security, Software Development, & Auditing) o Integration Verification & Validation  Unit, Integration, and System Acceptance Testing  IOPD/Q's  Factory & System Acceptance Testing o Laboratory Systems (Chemistry, Assays, Automation & Robotics) o Full Validation cycle (Master Validation Plan) with complete validation documentation  Quality System Requirements (QSR), cGxP's o Development, integration and training of clients staff with Quality System Requirements o Audits (first and second party) internal, external, pre-FDA inspections, ISO 9001:2000 o Medical Device (21 CFR 820), ISO 13485 o Finished Pharmaceuticals (21CFR 210, 211) o Biologics (21 CFR 600) o Human Cell & Tissue (21CFR 1271)  Software Development, Test, Integration and Compliance (V&V) for Class II & III Medical Device  Risk Assessment and Management, Hazard Analysis ISO 14971 & 16085  Human Factor Engineering (AAMI HE48 and FDA)  Corrective and Preventative Action (CAPA)  DFMEA, FMEA, Gage Reliability and Repeatability (G,R&R), SPC & ANOVA  Method Validations for Pharmaceuticals, Medical Devices and Combination Products  IT Network & Infrastructure testing and verification, penetration testing, vulnerability assessments for Internet, Intranet and Extranets  Contract Manufacturing (Proto-types, small production up to 5000 units) in Class 10,000 clean-room Advanced Medicals Consortium - Advanced Medicals Consortium's vertical integration allows our clients the benefit of industry expertise in the Medical Device, Pharmaceuticals and Biotechnology domains. Our qualified national associ
RegRx Consulting, LLC - Drug Regulatory Affairs Services: Overall regulatory development strategy, Interactions with FDA and other regulatory authorities, Negotiating labeling with FDA, Maintaining INDs during development, Maintaining NDAs post approval, Review of advertising and promotional campaigns including new product launches, Review of press releases, Management of OIG/PhRMA Code compliance, Due diligence, US Agent services. Regulatory Applications: New Drug Applications (NDA), Investigational New Drug Applications (IND), Common Technical Documents (CTD), Clinical Trial Applications (CTA), Abbreviated New Drug Applications (ANDA), Orphan Drug Applications, Amendments, supplements, annual reports, safety reports, Registrations, drug listings, 505(b)2 applications RegRx Consulting, LLC - RegRx Consulting, LLC provides consulting services to US and foreign pharmaceutical companies who need assistance with development and commercial drug regulatory affairs. We are a select group of h
Riverpharm Regulatory Consultancy - Riverpharm Regulatory Consultancy -
K Friedman Consulting - Pharmaceutical Regulatory Affairs: Preparation of CTA (clinical trail applications), CTAA (clinical trial application amendments), NDS (new drug submissions), SNDS (supplemental new drug submissions), ANDS (abbreviated new drug submissions), post-approval changes (notifiable changes, SNDS), responses to Notices of Deficiency from Health Canada on all of the above, Development and preparation of product monographs. OTC Products: Preparation of DIN (drug identification number) applications, NHP (natural health product) license applications and site-license applications, complete response to IRN (information request notices) for NHP product license/site-license applications. Other Consulting Services: provide input on regulatory strategy for timing and content of submissions, provide input as expert witness in litigations involving patents or other issues related to NOC regulations in Canada. K Friedman Consulting - K Friedman Consulting provides regulatory approval services for manufacturers of prescription and over-the-counter pharmaceuticals and natural health products (NHP). K Friedman also provides clinical
Sirega - Regulatory strategy Pharmaceutical writing / CMC documentation:· CTAs/INDs: IMPDs · Scientific Advice: Briefing packages · Marketing authorization applications, Variations, Renewals: CTD Modul 3, Quality Overall Summaries (QOS) · Stability/Analytical Reports Regulatory strategy · Scientific translations: German - English, English - German, Swedish -English, Swedish - German Medicinal products covered: · NCEs, Generics · Biologicals, Biosimilars · Advanced Therapies medicinal Products (ATMPs) Sirega - Sirega is a regulatory affairs consultant with 10 years professional experience in the pharmaceutical industry. Sirega covers all kinds of medicinal products and has specialized in Biotechnology and
B&C Business Company - Regulatory Affairs: services provided § Legal support for companies, preventive consultancy, analysis and contracts drawn up accordingly with regulatory standards; § Trading authorization (company`s authorization) for companies and registration of products with Anvisa and Ministry of Agriculture in the areas of food, drugs and medicines, nourishment, cosmetics, medical devices and health equipments, household cleaning products and veterinary products; § GMP approval. ANVISA: The Brazilian Regulatory Agency The Brazilian government establishes specific regulations for the registration and licensing or exemption of Life Sciences products. The National Health Surveillance Agency - ANVISA - was established in 1999 to foster protection of the health of the population by exercising sanitary control over production and marketing of products and services subject to sanitary surveillance. Ministry of Agriculture The Brazilian government establishes specific regulations for the registration and licensing or exemption of products under Ministry of Agriculture's inspection, such as milk, honey, beef, pork, wine, vegetables, veterinary medicines and animal feeding etc. B&C Business Company - B & C Business and Company ® is able to handle administrative and bureaucratic procedures with the regulatory bodies. We specialize in Regulatory Affairs, providing legal and regulatory support in Bra
CanReg Inc. - Regulatory consulting for all stages of development. CanReg Inc. - CanReg is one of North America's largest consulting firms dedicated exclusively to regulatory affairs for life sciences companies. Our clients benefit from the extensive experience of more than 100 i
GlobalReg Compliance Associates, Inc. - GlobalReg Compliance Associates, Inc. - GlobalReg Compliance Associates, Inc., specializes in offering a full complement of customized, process-based solutions for establishing comprehensive, sustainable regulatory and quality systems in th
Oracle Consulting Group - * All Medical Device Compliance Activities * All FDA Compliance Activities * U.S. Agent Services * Official Correspondent Services * GMP/Quality System Procedures * Submissions, 510(k) and PMA * FDA Inspection Readiness and Response * Warning letter Responses * Medical Device Reporting Activities * Audits, Internal and Supplier * FDA Compliance Training * Surveys, Client and Marketing Oracle Consulting Group - Consultants to Worldwide Medical Device Manufactures Regulated by the U. S. Food and Drug Administration. Our medical device consulting services include: * All Medical Device Compliance
SSPCC - SSPCC provides and specializes in Toxicokinetics, Analytical/bioanalytical support, Formulation and stability studies, Core and supplemental Safety Pharmacology the ICH S7A/S7B guidance's, Data management, Statistical assessment services, Recommendation of package of preclinical studies needed for new drug applications through to Phase IV regulatory requests Development of Safety Assessment Package, as independent 3rd party consultant to provide unbiased selection of appropriate studies, design, and cost analysis Liaison and project management of CROs, pulling together all the individual studies to centralize, oversee, and streamline the process Coordination and management of documentation for New Drug Applications (NDA) and Investigational New Drugs (IND) Liaison for academic institutions and pharmaceutical companies Independent 3rd party review of Good Laboratory Practices (GLP) Lab planning and budgeting Coaching of new recruits from academia to better transition them to the differing demands of the pharmaceutical industry and regulatory requirements Streamlined processes and procedures Staffing help during cyclical periods of overload SSPCC is poised to help you secure corporate funding, venture and private equity in addition to the following services: Facilitating corporate partnering between companies Identifying and in-licensing/out-licensing technologies and products Developing and implementing business plans Providing interim business development management for early stage companies Assessing technologies, intellectual property, products and providing valuations Access to capital Developing and implementing product development plans to support licensing approval SSPCC - SSPCC works within the early drug development space to support companies in their preclinical studies, program strategy and IND submissions. We achieve this by bringing together multidisciplinary tea
JD Consulting - Manufacturing Problem Solving We can help you improve quality and lower costs. Materials expertise in plastics, latex, silicone and urethane. Manufacturing process, injection molding, package and sterilization expertise. We have helped manufacturers: reduced their risk rating by 83% increase productivity by 80% saved hundreds of thousands of dollars by innovative problem solving to reduce waste and increase productivity identify the root cause and solve numerous quality problems See the complete list of Manufacturing Problem Solving Services... See some of our Manufacturing Accomplishments... Quality/Regulatory Compliance ISO 9000/CE/QSR compliance includes design control, FMEA, audits, validations and effective solutions to regulatory problems. helped prevent product recalls resolved customers problems with the FDA 510(k) submissions and timely approvals implemented quality programs that pass FDA and ISO audits completed process, package and sterilization validations JD Consulting - JD consulting is a technical consulting firm to the medical field specializing in manufacturing problem solving, developing quality systems including audits, design control, FMEA, quality engineering
Michor Consulting e.U. - European Authorized Representative for CE Marked Products for Global Partners Michor Consulting e.U. - At Michor Consulting our mission is to provide the highest quality services for our clients at the right time. Whether you are seeking advice in regulatory or quality issues from conception and planni
MORIAH Consultants - Regulatory Affairs, GXP compliance, drug development, regulatory compliance, clinical research, product strategy, strategic development, expert witness testimony, IT, Medical Writing, FOI Teleconferences, GMP compliance, Review of client technical dossiers and developmental plans, Research and interpretation of applicable local regulations, Determination of regulatory status, Review and support of manufacturing/GMP issues, Pre-submission review of technical documents, Critical writing and review of documentation, Writing, review, and compilation of submissions, Clinical trial applications and notifications (IND, IDE, CTX, etc.), Marketing Application Support (NDA, BLA, ANDA, 510(k), PMA, etc.), Orphan Drug, Treatment Use, and ANDA Suitability petitions, Company representation before regulatory officials MORIAH Consultants - Dr. Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located near Los Angeles, CA. He has worked in drug development, clinical researc
John Simon & Associates Ltd. - Regulatory Submissions, Compliance Auditing, Pre-approval Inspection Preparation, Batch record creation and review, validation protocols and reports, GMP Training John Simon & Associates Ltd. - John Simon and Associates offers Quality Assurance and Regulatory Affairs services to the Biotechnology Industry. We have a wide range of experience covering various stages of product development.
Medcore Consulting - EU regulations Training, APAC regulations Training, RUB regulations Training, compilation of complex submission files, submission files for suitability, compliance for GHTF, AHWP and ASEAN regulations, Training in STED and CSDT submission format,Risk Analysis and Essential Requirements / principles, Technical Documentation, Labelling and Language Compliance, Import/Export advice Medcore Consulting - MedCore Co., Ltd. is an independent European and Asian based regulatory consultancy company for the medical devices industry, with its headquarters in Bangkok, Thailand. The solid knowledge and exp
Okapi Consultants, LLC - Okapi Consultants, LLC. has expertise in many aspects of clinical development including: * Scientific review, * Preclinical scientific evaluation and development, * Protocol writing, * CRF development, * Document preparation, * IRB submission, * Investigative site identification and preparation, * Site management, * Regulatory compliance, * Monitoring, * Statistical analysis (outsourced), * Report writing Okapi Consultants, LLC - In 2001, Dr. Robert Levy and Ms. Teresa Barrett formed Okapi Consultants, LLC. Combining more than 20 years of experience in (mainly early phase) clinical trials work and industry consultation we crea
Amogha Pharma Consultancy - Amogha Pharma Consultancy - Amogha Pharma Consultancy was started by Gurudatta GG in Feb 2006 ,having a vast experience of 22 years in various areas of Pharma Industry. He has worked in Quality Control department, Quality ass
Regulatory Affairs and Quality Consulting - Global Regulatory Services Whether for one aspect of a project or complete support from inception to approval, we can help with: * Strategic planning from design to market for global markets. * CTD/eCTD preparation and submission for new drugs, generic drugs and clinical trials. * CTD/eCTD compatibility formatting across global regions. * Representation/Official correspondent to governing regulatory bodies (FDA/TPD/EMEA). * Drug Master File preparation and submission. * Risk management (warning letters, consent decree representation, recall strategies). * Labeling and advertising preparation and review. * Phase I-III meetings * Trial study initiation and monitoring Quality Systems Services * Quality systems design and auditing * Inspection readiness and coordination * Corrective action planning * Vendor audits * SOPs, documentation and implementation Regulatory Affairs and Quality Consulting - With over 30 years of experience in the pharmaceutical industry, our company has the knowledge to bring your innovations and ideas to the market. From initial drug development, through submission, ap
AUK Technical Services LTD - Dennis M Moore is currently Managing Partner of Auk Technical Services LTD, Beverly Hills, CA. Mr. Moore has 27 years of experience in medical device design, quality systems training, pharmaceutical manufacturing and 21 CFR 210,211 quality systems. Mr. Moore also has extensive experience helping firms achieve compliance to FDA regulation and International Standards regulations. Mr. Moore has extensive experience as an FDA Investigator, California Medical Device Senior Investigator, Sworn Government-POST Certified Criminal Investigator, Lead Trainer, Compliance Officer and company Chief Technical Expert and CEO. AUK Technical Services LTD - Auk Technical Services LTd has been in operation since 2004, and provides the following services: -training for Quality System Regulation, design control, process design, compliance achievement
RJR Consulting, Inc. - At RJR Consulting, Inc., we believe in the power of experience. That's why our global network of consultants is only staffed with senior professionals, all experts in their respective fields. That way, we can deliver high-level solutions more efficiently - solutions that might otherwise be hindered by longer learning curves and inexperience of junior-level associates. Following is a list of services we have provided to clients throughout the world. Technology Development  Material selection, new product development, product improvement and product design.  Reverse engineering of product cost-to-produce economics. Manufacturing Solutions & Implementation  New process development  Troubleshoot current process problems  Line / process design, equipment selection / vendor qualification Process Improvement  Identify areas for lowering ongoing manufacturing costs  De-bottlenecking / rate determining step  Utilization of Six Sigma / quality tools in analyses Global Regulatory Compliance & Government Affairs  Global product compliance; country regulations  Representation of company & products to specific agencies, governments, commissions International Trade & Sourcing  Compliance with international trading laws and regulatory requirements (U.S., Canada, Europe, Asia, Latin America)  Global product sourcing & shipment facilitation  U.S. & International Customs interface Quality Systems Development & ISO Compliance Auditing  ISO compliance & certification  Quality Systems development  Establish / install ongoing management system for self compliance  Audit programs / self audit training Market Research / Industry Analysis & Trends  Targeted studies; regional, global  Industry contacts / databases  Specific, affordable studies -- built and priced to client's needs Business Strategy Development: 1,3 & 5-Year term Strategy Development  Initial strategy development  Review existing plans / revitalize growth, provide focus, functional plans  1,3 & 5 Year build including strategic goals, economic plan & SWOT analyses SAP Software Domain Experts  Xem (emissions module)  Xpd (new product development & stage-gate system development) Venture Capital Placement / Acquisition Facilitation  Opportunity / candidate identification  Due diligence on identified candidates  Facilitation of business arrangement / negotiations Government Business Development  GSA listings / application development and submittal service  Opportunity analysis ; available government business & focus  On-line procurement training  Meeting facilitation Grant Writing  Technical / business / educational submittals  Grants written, filed, monitored and facilitated  Federal, State, Private funding sources RJR Consulting, Inc. has also worked with niche companies whose needs do not fall into a standard classification or category. If you are a highly specialized company or organization that requires more customized, unique solutions than those listed above, please don't hesitate to contact us. We love a challenge, and there's a good chance we already employ the tools and experience necessary to improve your business. RJR Consulting, Inc. - RJR is an international consulting firm serving companies, organizations, and governments around the world including North America, South America, Europe, Africa, and Asia. With headquarters in Midlan
Reg Clarity Inc. - Key service areas include strategic planning and performance on all client regulatory and quality needs throughout the product lifecycle, from design inception (R&D) through formalized development and testing, regulatory interface for clinical trails and product submissions for market release. Primary service areas also include Quality Management System (QMS) design, assistance on internal audits and mock external audits, CA/PA resolution and closure, review of product labeling, advertising and promotional materials (including website content) and press releases; field actions and recalls; product obsolescence and data archival/document control requirements. RCI does not provide services related to clinical study design, clinical statistical analysis, GCP audits or design and development standards for individual device categories; these services are provided by specialist partner organizations. Reg Clarity Inc. - Reg Clarity Inc (RCI) serves medical device companies distributing product in the USA, Canada and Europe. Our expertise covers Class III (USA) implantable medical devices as well as lower risk and/or
Universal Regulatory, Inc - 1. Regulatory Strategy and Planning Strategic Interactions with Global Health Authorities - Pre-IND, EOP2, pre-NDA, Scientific Advice Preparation and review of regulatory submissions IND, CTA, DMF, NDA, MAA Non-Clinical, CMC, Clinical Amendments Orphan Drug Designation Special Protocol Assessments (SPA) Request for Fast Track Designation IND Annual Report, DMF Annual Update Target Product Profile Product Development Plans with Global Regulatory Considerations Regulatory Oversight on Project Teams Product Research and Review of Summary Basis of Approval 2. Regulatory Oversight of Worldwide Clinical Trials Authoring Responses to Questions from Global Health Authorities and Ethics Committees Review and Approval of Investigator Packages for Shipment of Clinical Trial Supplies 3. Due Diligence Providing Regulatory Representation on Due Diligence Teams for On Site/Remote Due-Diligence Activities Technology and Expert Regulatory History Research 4. Regulatory Operations Support Assembly of Regulatory Submissions Document Management of Regulatory Documents and Record of Correspondence with Health Authorities Project Management of Large, Multi-Volume, Multi-Disciplinary Submissions Universal Regulatory, Inc - Universal Regulatory Inc offers comprehensive consulting services in Regulatory Affairs by combining strong technical expertise in pharmaceutical development with knowledge of global regulatory enviro
Clairvoyance Consulting - Clairvoyance Consulting - Clairvoyance Consulting is a Proprietorship firm promoted by Ashish Jose that provides consultancy services to the Manufactures and Importers of Medical Devices and Diagnostic Kits in the area of Regu
Clinivation - Global Market Clearance Services, including strategic and operational market clearance program development, support, and execution. The clinivation Global xi enterprise solution for Market Clearance Management enables executives and their teams to address the challenges of execution, effective governance, and lean business performance in their global market clearance operations. Only clinivation Global xi accelerates the market clearance cycle to advance new worldwide revenue and achieve new milestones of enterprise value. Clinivation WorldView is the medical device and diagnostic industry's most comprehensive, authoritative, and up-to-date enterprise solution for On-Demand Global Regulatory Intelligence. Providing clear, step-by-step market clearance regulations, processes, and guidance for >99% of the world markets, only clinivation WorldView delivers tried-and-true intelligence from certified, practicing professionals with real-world experience. Clinivation - Clinivation is the leading provider of integrated solutions that enable global market clearance. Guided by our singular vision- "Excellence in Market Clearance"- clinivation accelerates the entire mar
Emergo Group - Consulting for European CE Marking, Technical Files, FDA 510(k) clearance, STED, Japan PAL, China SFDA approvals, and Canadian licenses and other international regulatory compliance issues. Assistance with US FDA Quality System Regulation and ISO 13485 consulting, QMS audits, Japanese quality system requirements, internal auditor training and other quality assurance services. Global in-country representation for: European Authorized Representative, China Legal Agent, Japan Marketing Authorization Holder (MAH), Mexico Registration Holder, US FDA Agent and Australia TGA Sponsor. We help find and qualify medical distributors in Europe, including France, Germany, UK, Italy and Spain and other EU countries plus Japan, Mexico, China, Australia, Canada and the USA. * SFDA Medical Device Approvals * Legal Agent and After Sales Agent Representation * CCC Mark Certification * Chinese Medical Distributor Search * Clinical Trial Consulting and Clinical Research in China (CRO) Documentation * FDA 510(k) Clearance for Medical Devices * FDA cGMP Quality System Implementation Consulting * US FDA Agent Representation * US Medical Distributor Search * FDA GMP Overview Training * FDA GMP Quality System Audits * FDA Form 483 or Warning Letter Response * FDA 513(g) Consulting for Medical Devices * ISO 14971:2007 Risk Management * Validation Consulting for Processes, Equipment and Software * Quality System Audits and Gap Analysis * Due Diligence Audits to Determine QA & RA Compliance * Internal Auditor Training (ISO 13485 and FDA QSR) * ISO 13485 Quality Management Systems Consulting * ISO 13485 Training * ISO 14971 Risk Management Consulting * ISO 14971 Training * Medical Device Classification Consulting * Quality Assurance & Regulatory Affairs Outsourcing * Software, Equipment and Process Validation Consulting Emergo Group - Emergo Group is an ISO registered medical device consulting firm. By focusing on providing outstanding customer service and value for our clients, we have grown to become one of the leading medical de
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