LAXAI is a leading provider of Drug Research and Development services and Clinical Research Support services for Life Sciences industry across Americas, Europe, and Asia.

LAXAI’s United States operations serve life sciences organizations by providing wide spectrum of clinical research support services executed from its offsite facility at South Plainfield, NJ and client’s location.

LAXAI AVANTI Life Sciences Pvt, Ltd. in India provides contract Drug R&D outsourcing services ranging from drug discovery to regulatory submissions. LAXAI AVANTI Life Sciences Pvt, Ltd is promoted by the LAXAI and the AVANTI group, one of India’s reputed publicly listed corporations. With a history of leadership and credibility, LAXAI is renowned for its high standards of quality, ethics and commitment.

LAXAI has an excellent track record of successfully completing R&D and Clinical Research Support service projects for several large to small US, Europe and Asia based biotech, pharmaceutical and CROs.

Our presence in USA, Europe and India helps us enhance the productivity and efficiency of Bio-Pharma R&D programs globally to unprecedented levels of cost-effectiveness and quality by bringing together global expertise with the talent and the India advantage with the following differentiators:

• No conflict of interest (LAXAI is not -a product company)
• No IP Concerns
• No Capital Costs
• Follow the Sun Advantage with India presence
• Offsite, Offshore and Blended Delivery Models
• Access to diverse talent across US and India
• Minimum risk to realize maximum savings
• Ability to own under Build, Operate Transfer model
• No Geopolitical issues to deal with
• Complete control with local management oversight
• In-house training to ensure quality
• Regulatory support

LAXAI with its experienced team offers customers to conduct Drug R&D programs in an accelerated and cost effective manner. We provide a wide range of capabilities in the drug value chain, including custom synthesis of reagents, focused compound library design, rapid analoging, building blocks/Scaffolds, intermediates and reference/standard. LAXAI can scale up the processes up to multi kilogram scale using the pilot plant facility. We have an excellent team to support the analytical research needs for drug R&D. LAXAI provides Facilities, Infrastructure and Resources to meet specific needs of customer using GxP guidelines for the following:

• Medicinal Chemistry
• Process Development, Optimization and Scale Up
• Analytical Research

LAXAI provides superior Clinical Research Support services. Our solutions are designed to address the bottlenecks in Drug R&D by

• Reducing costs using innovative outsourcing models
• Improve operational efficiencies
• Reduce Time-to-Market for new drugs

We have a thorough understanding of GCDMP, CDISC standards and FDA regulatory requirements. LAXAI has years of experience with industry leading products used in Clinical Research like Oracle Clinical, RDC and AERS, Phase Forward Inform and ClinTrial, Medidata Rave and SAS.

• Data Management
• Electronic Data Capture (EDC)
• Biostatistics and SAS Programming
• CDISC Consulting
• Medical Writing

We have a talent pool of experienced clinical research and support services professionals to augment your Clinical Research resourcing needs. Our strong ties within the life sciences community have enabled us to become a leading provider of contract professionals for the pharmaceutical, biotech, CRO and related industries for the following requirements.

• Clinical Trial Managers
• Data Managers / e-Data Managers
• Data Validation Associates
• CDISC Consultants
• Bio-Statisticians
• SAS Programmers
• Clinical Database Programmers
• CRA’s (in-house and regional) and CRC's
• Regulatory Affairs Associates
• Drug Safety

LAXAI provides state-of-the art solution centers in South Plainfield, NJ and Hyderabad, India. The backbone of the data center is a high speed communication link with Virtual Private Network and Network Management Services with access Control mechanisms. The access controls include a combination of Physical and Logical access control as per 21 CFR Part 11 guidelines with provisions for backup and restoration of data tapes. The tapes are stored at a secure facility as per SOPs and BCP/ DR procedures. The infrastructure includes high-availability, secure rack mountable machines which are installed and configured as per IQ/OQ specifications provided by the manufacturer. We have SOPs regarding access control and data management and our Quality Managers ensure that there are no process deviations. We constantly audit our facility to address compliance related issues

Our laboratory facilities are very well equipped with the latest equipments and analytical instruments to handle complex reactions and synthesis efficiently at laboratory and pilot scale. Our experienced pool of team comprises PhDs, Post Doctorates and Masters in Organic, Medicinal and Analytical Chemistry. Our team can execute tasks involving complex reactions and synthesis efficiently. We have wet lab space of 8,000 sq ft and scalable to 140,000 sq ft to cater clients with different engagement models. We have SOP’s driven facilities and our Labs are GLP/GMP compliant.

We have dedicated NMR (400 MHz), LC/MS, HPLC , Prep HPLC, Microwave Synthesizer, Combiflash, stability chambers, hydrogenators and other necessary equipments and instruments to support drug R&D (NCEs / NBEs, APIs, Reagents and other intermediates)

FTE (FULL TIME EQUIVALENT) MODEL:
LAXAI outsourcing platform offers a comprehensive Full Time Equivalent (FTE) engagement model tailored to meet each client’s need for rapid synthesis of research compounds or Data Management Services.

We also offer custom synthesis services using fixed cost model based on per reagent, intermediate compound in milligrams to kilograms quantity.

CAPTIVE MODEL:
LAXAI offers Captive engagement model which helps biopharmaceutical companies to achieve better control compared with traditional outsourcing models. Many pharmaceutical and biotech companies have discovered that there is a need to reduce cost, ease backlogs and capacity shortages. LAXAI provides clients with dedicated facilities, resources and infrastructure in such a way that the client feels that it is an extension of their own facility.

BUILD, OPERATE AND TRANSFER (BOT) MODEL:
Global Biopharmaceutical companies have come to appreciate the advantages of conducting R&D in India and that the option has been increasingly a "must to do" to have R&D operations in India.

However there are several challenges that companies face like setting up infrastructure, building teams, dealing with geo-political and regulatory issues and of-course the huge capital costs involved.

LAXAI enables Biopharmaceutical companies to rapidly start their R&D operation in India, realize the cost savings make them sustainable and then transfer then as their own subsidiary.

Contact Information

LAXAI
Vamsi Maddipatla
No.9, ICICI Knowledge Park,
Genome Valley, Turkapally, Shamirpet,
Hyderabad, Andhra Pradesh 500078 INDIA
Phone: 001-908-756-7300 ext. 306 (USA)
Fax: 001-609-642-4541 (USA)
E-mail:

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