Intercell Approves Novatek International Suite of Software Products.

PDA/FDA meeting, Sep 2007, Novatek International is pleased to announce that it is now an approved vendor under the Software Quality Assurance Audit of Intercell (Livingston, Scotland), one of the leading biotechnology companies in Europe.

Intercell's Software Quality Assurance Audit covers procedures and practices in developing, testing, installation, validation and supporting its software for laboratory information management system.

We like to welcome Intercell as our newest client joining the ranks of prestigious clients such as J&J, Pfizer, Schering Plough, Novartis, etc, in Four Corners of the world.

Intercell has chosen Novatek’s Environmental Monitoring solution to control activities and data within their extensive quality, and research and development divisions. Novatek International is pleased to welcome Intercell, Scotland to the ranks of other prestigious clients such as Novartis, Pfizer, Schering Plough, lifenet, Sanoffi-Aventis among many more, in the four corners of the world.

Environmental Monitoring Program is an application capable of capturing all environmental data in a 21 CFR Part 11 Compliant, fully validated system. It is envisioned for sterile and non sterile health care industries (Pharmaceuticals, Biotech, Chemical, microbiological) food and any other sterile environment based on the latest guidelines from, FDA, EU, ISO 14644-1 and PDA Technical report 13. Data from viable and non viable monitoring, Water analysis, clean steam and compressed gases are securely captured and easily trended to ensure site "state of control". The investigation window allows the user to investigate Out of Specification "OOS" with capability to add any files such as picture, audio video, scanned documents etc to the report.

About Intercell:
Intercell AG is a growing biotechnology company which focuses on the design and development of novel vaccines for prevention and treatment of infectious diseases with substantial unmet medical need. The Company develops antigens and immunizers (adjuvants) which are derived from its proprietary technology platforms, and has in-house GMP manufacturing capability. Based on these technologies, Intercell has strategic partnerships with a number of global pharmaceutical companies, including Novartis, Merck&Co., Inc, sanofi pasteur, Kirin, Wyeth, and the Statens Serum Institut. The Company’s lead product, a prophylactic vaccine against Japanese Encephalitis has successfully concluded pivotal Phase III clinical trials. The regulatory process towards a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) has been initiated. The broad development pipeline includes a therapeutic vaccine for Hepatitis C in Phase II, a Pseudomonas vaccine in Phase II, partnered vaccines for Tuberculosis and S. aureus which are in Phase I, and five products focused on infectious diseases in pre-clinical development.

Novatek International, the pioneer of 21 CFR Part 11 compliant LIMS would like to announce that Unither in Maryland, USA has chosen Novatek’s Environmental Monitoring solution to control activities and data within their extensive quality, and research and development divisions. The Environmental Monitoring Program will take Unither into the future with safe and dependable data storage and mining tools. Novatek International is pleased to welcome Unither to the ranks of other prestigious clients such as Forth Dodge (Wyeth), Gensia Sicor, J&J, Cangene, Schering Plough, Novartis and more, in the four corners of the world.

Environmental Monitoring Program is an application capable of capturing all environmental data in a 21 CFR Part 11 Compliant, fully validated system. It is envisioned for sterile and non sterile health care industries (Pharmaceuticals, Biotech, Chemical, microbiological) food and any other sterile environment based on the latest guidelines from, FDA, EU, ISO 14644-1 and PDA Technical report 13.

Data from viable and non viable monitoring, Water analysis, clean steam and compressed gases are securely captured and easily trended to ensure site "state of control". The investigation window allows the user to investigate Out of Specification "OOS" with capability to add any files such as picture, audio video, scanned documents etc to the report.

About Unither
United Therapeutics is a biotechnology company focused on the development and commercialization of unique products for patients with chronic and life-threatening cardiovascular, cancer and infectious diseases. In these segments, United Therapeutics is actively developing four technology platforms: Prostacyclin Analogs, Immunotherapeutic Monoclonal Antibodies, Glycobiology, and Telemedicine.

Novatek International, the pioneer of 21 CFR Part 11 compliant LIMS would like to announce that Cadista Corporation a subsidiary of Jubilent Organosys Pharmaceuticals has chosen Novatek’s solutions to control activities and data within their extensive quality, and research and development divisions. Novatek International is pleased to welcome Cadista, in Maryland, USA to the ranks of other prestigious clients such as APEX Pharmaceuticals, Pfizer, Schering Plough, Novartis among many more, in the four corners of the world.

Advanced Quality Nova-LIMS is a 21 CFR Part 11 Compliant long-term LIMS solution that ensures you have centralized control and maintenance of all your data handling software solutions. It is a client/server product comprised of specialized functional modules such as the Environmental Monitoring Module, the Stability Module, the Raw Material Analyzer, the Finished Product Analyzer, the Calibration and Preventive Maintenance Module, the Automated Packaging Component Analyzer and Document Management System, audit and training Module.

About Cadista:
Cadista Pharmaceuticals Inc., a subsidiary of jubilant Organosys is a generic pharmaceutical company having US FDA approved manufacturing facility for solid dosage forms in the Salisbury, Maryland, USA. Cadista Pharmaceuticals has, in its portfolio, 9 approved ANDAs.5 ANDAs are filed and awaiting approval. 30 more ANDAs are in the pipeline. Jubilant Organosys Limited is an integrated pharmaceutical industry player with a wide range of products and services for global life sciences companies. The Company is one of the largest Custom Research and Manufacturing Services (CRAMS) and Drug Discovery and Development Services organizations in India.

Novatek International, the pioneer of 21 CFR Part 11 compliant LIMS would like to announce that Lonza (VISP, Switzerland) has chosen Novatek’s Environmental Monitoring solution to control activities and data within their extensive quality, and research and development divisions. Novatek International is pleased to welcome Lonza, Switzerland to the ranks of other prestigious clients such as Novartis, Pfizer, Schering Plough, lifenet, Sanoffi-Aventis among many more, in the four corners of the world.

Environmental Monitoring Program is an application capable of capturing all environmental data in a 21 CFR Part 11 Compliant, fully validated system. It is envisioned for sterile and non sterile health care industries (Pharmaceuticals, Biotech, Chemical, microbiological) food and any other sterile environment based on the latest guidelines from, FDA, EU, ISO 14644-1 and PDA Technical report 13.

Data from viable and non viable monitoring, Water analysis, clean steam and compressed gases are securely captured and easily trended to ensure site "state of control". The investigation window allows the user to investigate Out of Specification "OOS" with capability to add any files such as picture, audio video, scanned documents etc to the report.

About Lonza:
Lonza is the premier custom manufacturing company with a broad tool box of capabilities and technologies. In addition to our customer focused approach, we are uniquely able to offer our clients synergies between chemical synthesis and biotechnology to enable the production of tailor-made intermediates and API’s for use as pharmaceuticals, biotherapeutics, nutraceuticals and animal health products. Lonza's product line encompasses a whole range of high-value added chemicals, problem-solving solutions and services for a wide range of industries, including life sciences, human and animal nutrition, chemical, cosmetics and personal care, household, industrial and institutional cleaners, water treatment and wood preservation. Lonza has the market-leading position in a number of areas, including cell-based research products, endotoxin detection systems, and cell-based therapeutic manufacturing, as well as highly regarded products for cell culture and electrophoresis.

Novatek International, known worldwide for leadership in pioneering 21 CFR Part II compliant solutions for the entire product life cycle of healthcare quality operations, is pleased to announce the addition of Transcept Pharmaceuticals to their prestigious list of clients. Transcept based in California, USA has chosen the stability software program solution to control activities and data within their extensive quality, and research and development divisions.

Advanced Quality Nova-LIMS is a 21 CFR Part 11 Compliant long-term LIMS solution that ensures you have centralized control and maintenance of all your data handling software solutions. It is a client/server product comprised of specialized functional modules such as the Environmental Monitoring Module, the Stability Module, the Raw Material Analyzer, the Finished Product Analyzer, the Calibration and Preventive Maintenance Module, the Automated Packaging Component Analyzer and Document Management System, audit and training Module.

About Transcept Pharmaceuticals:
Trancept Pharmaceuticals based in Point Richmond, CA, is a specialty pharmaceutical company CNS platform targeting insomnia and alcohol dependence,

Novatek International, the pioneer of 21 CFR Part 11 compliant LIMS would like to announce that Macroflux Corporation, a subsidiary of Johnson and Johnson located at California USA has chosen Novatek’s NOVA-LIMS solution to control activities and data within their extensive quality, and research and development divisions. Novatek International is pleased to welcome Macroflux to the ranks of other prestigious clients such as, Novartis, Pfizer, J&J among many more, in the four corners of the world.

Advanced Quality Nova-LIMS is a 21 CFR Part 11 Compliant long-term LIMS solution that ensures you have centralized control and maintenance of all your data handling software solutions. It is a client/server product comprised of specialized functional modules such as the Environmental Monitoring Module, the Stability Module, the Raw Material Analyzer, the Finished Product Analyzer, the Calibration and Preventive Maintenance Module, the Automated Packaging Component Analyzer and Document Management System, audit and training Module.

About Macroflux:
The Macroflux Corporation is an emerging specialty pharmaceutical company focused on the development of novel proprietary products via the Macroflux® technology. The Macroflux Corporation was originally a group within ALZA Corporation and was spun out through Johnson and Johnson Internal Ventures in October of 2006. The Macroflux technology is intended to provide a needle-free solution for delivery of peptides, small molecules, proteins and vaccines. Based on a small patch and applicator, Macroflux technology is designed to combine painless and convenient drug administration with rapid delivery and high bioavailability.

Novatek International, a world leader that provides a broad range of compliant software solutions to the Medical Devices, Pharmaceuticals, Tissue Banks, Biotechs, Biologicals, and Contract labs, announced today that they are pleased to welcome Pfizer, Venezuela. Pfizer joins a long list of companies using Novatek’s Stability Program, a list including such distinguished companies as Johnson & Johnson in US, Novartis in India, PolPharma in Poland, Advanced Pharmaceuticals in Jordan, Technofarma in Argentina, to name a few.

Advanced Quality Nova-LIMS is a 21 CFR Part 11 Compliant long-term LIMS solution that ensures you have centralized control and maintenance of all your data handling software solutions. It is a client/server product comprised of specialized functional modules such as the Environmental Monitoring Module, the Stability Module, the Raw Material Analyzer, the Finished Product Analyzer, the Calibration and Preventive Maintenance Module, the Automated Packaging Component Analyzer and Document Management System, audit and training Module.

About Pfizer:
Good health is vital to all of us, and finding sustainable solutions to the health care challenges of our changing world cannot wait. That's why we at Pfizer are committed to being a global leader in health care and to helping change millions of lives for the better through providing access to safe, effective and affordable medicines and related health care services to the people who need them. We have a leading portfolio of medicines that prevent, treat and cure diseases across a broad range of therapeutic areas, and an industry-leading pipeline of promising new products in areas such as oncology, cardiovascular disease and diabetes.

To ensure that we deliver the value our patients and customers need and our shareholders deserve, we are focused on continually improving the way we do business; on operating with transparency in everything we do; and on listening to the views of all of the people involved in health care decisions. We know that we can best ensure that people everywhere have access to innovative medicines and quality health care through working in partnership with everyone from patients to health care providers, managed care organizations to world governments and non-governmental organizations.

Novatek International, the pioneer of 21 CFR Part 11 compliant LIMS would like to announce that APEX pharmaceuticals, India has chosen Novatek’s NOVA-LIMS solution to control activities and data within their extensive quality, and research and development divisions. Novatek International is pleased to welcome APEX Pharmaceuticals to the ranks of other prestigious clients such as, Novartis, among many more, in the four corners of the world.

Advanced Quality Nova-LIMS is a 21 CFR Part 11 Compliant long-term LIMS solution that ensures you have centralized control and maintenance of all your data handling software solutions. It is a client/server product comprised of specialized functional modules such as the Environmental Monitoring Module, the Stability Module, the Raw Material Analyzer, the Finished Product Analyzer, the Calibration and Preventive Maintenance Module, the Automated Packaging Component Analyzer and Document Management System, audit and training Module.

About APEX Laboratories ltd:
Apex laboratories ltd. is a leading manufacturer of Pharmaceutical formulations in South India. Established in the year 1978 by a budding team of first generation entrepreneurs, the company has pioneered the use of elemental zinc in their formulations (Under the dynamic leadership of Shri.S.S.Vanangamudi, Managing Director). apex has made rapid strides with leading brands with an all India presence.

The state of art manufacturing facilities are located at Alathur in the Sidco Industrial Complex about 40 Kilometres from Chennai close to the tourist town of Mahabalipuram. The facilities created conform to WHO-GMP standards with large capacities for the manufacture of liquids, capsules, tablets and Ointments. apex has also created state of art testing facilities conforming to cGLP standards to maintain end to end quality standards.

Novatek International, the pioneer of 21 CFR Part 11 compliant LIMS would like to announce that Azopharma has chosen Novatek’s solutions to control activities and data within their extensive quality, and research and development divisions for all sites in various countries (such as Argentina, Uruguay, Panama, Mexico etc in Latin America.

Novatek International is pleased to welcome Azopharma, Argentina to the ranks of other prestigious clients such as Montellier, Argentina, Technopharma Argentina, Pfizer, Venezuela, Sanoffi-Aventis, Mexico etc, in Latin America.