Dear Subscribers,

We have a new  play for you on Thursday! This is a company in the  pharmaceutical and medical fields.

Our latest Alpha alert is GATA, Group Athena Inc.

GATA is a research and testing organization and helps various pharmaceutical and medical products and devices companies in India and Southeast Asia to get regulatory approvals and facilitate exports of their products to the United States.

GATA accomplishes this by assisting clients from concept through development, providing consultation on regulatory requirements, filings and processes.

GATA has a research and marketing facility in India that currently employs 15 consultants and marketing personnel and is working towards aggressively expanding its presence in the Indian pharmaceutical industry.

The Company's web address is www.groupeathena.com

Company Overview

Serving India and South East Asia, GATA has been serving companies abroad in obtaining FDA approval for pharmaceuticals, medical products and devices for export to America. GATA's goal is to ensure each of our clients passes FDA inspection by assisting them from concept through development, with consultation through all the regulatory requirements, filings, and processes to achieve FDA compliance and approval.

With offices in India and America, the expert consultants of GATA are in position to go to target companies in Asia and the regulatory authorities in the USA directly, consulting with our clients in the East to serve them completely in providing consultancy services for FDA compliance. Services include providing technical and regulatory consulting for biotechnical products, pharmaceuticals [over the counter, prescription and generics], diagnostics, medical equipment, and devices.

The FDA inspection process is traditionally complicated, especially for foreign drug and medical companies trying to export to the USA. With broad spectrum consultancy and assistance through this process, our client base can count on reduced risk, follow-through on steps necessary for FDA compliance and identifying and solving breaches in compliance.

From concept through final approval, GATA navigates companies through every requirement of the process including pharmaceutical consulting, development, and regulatory compliance to achieve FDA approval and export pharmaceuticals and medical products and equipment to the USA.

Services Offered

• Analytical QC
• QA Functions
• Readiness for Inspections
• Compliance
• Validation
• Clinical Trial Management
• Regulatory/Legal
• Preparation of Regulatory Filings (IND's/PMA's/NDA's/ANDA's/510Ks etc)
• Compliance Assessments (GLP, GMP, GXP)
• Risk Assessments
• Mock FDA Audits
• Medical Device Support
• CMC Support
• GMP Training
• Facility Layout Consulting
• Utilities, Process, IT, Computer, and Cleaning Validation
• Training

Corporate Philosophy

 

With 12 consultants in offices in America and India, GATA is able to offer the highest quality assistance to Indian and South East Asian pharmaceutical and medical companies seeking FDA approval for their products to export to the USA. Education among their expert consultants include 3 PhDs, 9 Pharmacists, 2 MBAs and an attorney to provide a good knowledge of FDA rules and regulations, pharmaceutical knowledge and the corner stones to secure FDA approval for their clients.

 

 

GATA’s resources also includes a laboratory facility located in India to assist with testing and clinical trials for their clients.

 

 

With a proven track record reflecting the results, they are a highly flexible company positioned to lead through the FDA approval process, finding solutions to obstacles and consistently producing client satisfaction grounded on positive outcomes. GATA is streamlined to bring the best knowledge to benefit the clients as a team of professionals, dedicated to each project from start to finish. Combined with understanding of the entire FDA approval process, the American, Indian, and South East Asian mindsets and the right education and experience to be considered experts, GATA is the only FDA Consultancy to employ to navigate the FDA compliance journey.

 

Quality

 

Embarking on the journey to FDA approval can be frustrating and disappointing when the task is left in the wrong hands. GATA has a commitment toward each of their clients to provide the highest quality services and the most positive outcomes at the least expense to their clients. With unmatched knowledge of the FDA approval process, as well as experience and knowledge of the cultures in which they conduct their business, their consultants are ready to serve.

 

GATA takes the processes and strategies to obtain FDA approval seriously on behalf of their clients, and are proud when subsequent approvals lead to medical breakthroughs and economic prosperity on all sides of the world.

If you have missed some of our other Research and Testing Plays in the past, you have another chance as GATA could be our next big winner!

Best Regards,

AlphaPennyStock.com Staff

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