Groupe 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 announced revenues of $10,665,210 for the period ending March 31, 2016. Operating income before depreciation, amortization and taxes were $1,662,277 while net income was $1,233,147.
Total revenues for the 9 month period this fiscal year were an incredible $43,816,222 which is well on pace to meet the previously announced 12 month guidance.
Cash reserves in the form of short term investments and deposits are extremely healthy while long term debt remains virtually non-existent.
Groupe Athena, Inc. is increasingly focusing on exports to the United States and GATA is well positioned to help them get their products approved by the FDA for sales in the US.
All of these exporter companies are potential clients and the Company believes it has an advantage over competitors due to the facilities based in India, and their ability to deliver quick feedback to clients that could result in expedited order generation.
With recent additions to equipment, the company will continue to take on additional contracts and continue to anticipate further growth.
Groupe Athena, Inc. Posts Strong 3rd Quarter Results
MUMBAI, INDIA–(Marketwired – Apr 11, 2017) – Groupe Athena, Inc. (: ) announced today revenues of $10,665,210 for the period ending March 31, 2016. Operating income before depreciation, amortization and taxes were $1,662,277 while net income was $1,233,147.
Total revenues for the 9 month period this fiscal year were $43,816,222 which is well on pace to meet the previously announced 12 month guidance. Cash reserves in the form of short term investments and deposits are extremely healthy while long term debt remains virtually non-existent.
The Indian pharmaceutical industry is increasingly focusing on exports to the United States and GATA is well positioned to help them get their products approved by the FDA for sales in the US. All of these exporter companies are potential clients and the Company believes it has an advantage over competitors due to the facilities based in India, and their ability to deliver quick feedback to clients that could result in expedited order generation. With recent additions to equipment, the company will continue to take on additional contracts and continue to anticipate further growth.
About Groupe Athena, Inc.
Groupe Athena, Inc. was incorporated in June 2008 and began operations on July 1 of that year. The company 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. The Company accomplishes this by assisting clients from concept through development, providing consultation on regulatory requirements, filings and processes.
The company has a research and testing facility in India that employs 21 consultants and is working towards aggressively expanding its presence in the Indian pharmaceutical industry. The Company’s web address is www.groupeathena.com.
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Serving India and South East Asia, Groupe Athena has been serving companies abroad in obtaining FDA approval for pharmaceuticals, medical products and devices for export to America. Their goal is to ensure each of their 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 Groupe Athena are in position to go to target companies in Asia and the regulatory authorities in the USA directly, consulting with their 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, their 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, Groupe Athena 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.
Readiness for Inspections
Clinical Trial Management
Preparation of Regulatory Filings (IND’s/PMA’s/NDA’s/ANDA’s/510Ks etc)
Compliance Assessments (GLP, GMP, GXP)
Mock FDA Audits
Medical Device Support
Facility Layout Consulting
Utilities, Process, IT, Computer, and Cleaning Validation
With 21 consultants in offices in America and India, Groupe Athena 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. Their team includes 3 PhDs, 9 Pharmacists, 5 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 our clients.
With all Indian founders, Groupe Athena also has a reputation for being the first choice for FDA regulatory consultancy in the region for their ability to understand the obstacles and complications for Indian and South East Asian companies, as well as the requirements that would be expected by the Food and Drug Administration in America. They understand the values and the language and our experience and education on the subject matter, together with an absolute focus on client satisfaction and support has made us a leader in the field of FDA Consultancy.
Groupe Athena’s resources also includes a laboratory facility located in India to assist with testing and clinical trials for our clients.
They continuously strive to provide the most advanced consultancy services to aid medical and pharmaceutical companies in reaching their objectives. From concept to approval, Their professional consultants will guide each client through development, regulatory compliance, and ultimately passing FDA inspection and obtaining FDA approval.
With a proven track record reflecting their results, they are a highly flexible company positioned to lead you through the FDA approval process, finding solutions to obstacles and consistently producing client satisfaction grounded on positive outcomes. The company is streamlined to bring the best knowledge to benefit 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, Groupe Athena is the only FDA Consultancy to employ to navigate the FDA compliance journey.
Embarking on the journey to FDA approval can be frustrating and disappointing when the task is left in the wrong hands. Groupe Athena has a commitment toward each of our 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 services offer an initial consultation to enable them to plan and strategize with goals specific to your product or company’s needs. They deliver comprehensive consults throughout the inspection process including mock FDA inspections and mock product recalls to identify and solve breaches in compliance through assessment and modification. With the right knowledge about supplier audits, document preparation and filing processes, they are able to meet all regulations and requirements. They also provide guidelines to ensure quality throughout development.
Whether you are seeking FDA approval for biotechnical products, pharmaceuticals [OTC, prescription or generics], diagnostics, or medical equipment and devices, they have the quality resources to know what is needed during each step of the process to guide clients through it and to qualify. Their past and existing clients know their needs are met by professionals, who put client satisfaction as their number one priority.
Groupe Athena (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. www.groupeathena.com.