Groupe Athena, Inc. (Pink sheets GATA.PK)

On April 10th 2017 by OTC PR No Comments

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 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 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.

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

 

 

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. Our 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 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, professional consultants guide each client through development, regulatory compliance, and ultimately passing FDA inspection and obtaining FDA approval.

With a proven track record reflecting our results, we are a highly flexible company positioned to lead clients 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 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.

CASE STUDY ONE

lab6A medical device manufacturer had a failing QC testing group though group facilities in Europe had a higher rate of productivity and much higher rate of efficiency in terms of fewer laboratory investigations and samples analyzed.

The project was to analyze the situation and produce a new laboratory solution to establish at least parity with the European laboratory.

The Process:

Both laboratories were assessed using PERT/CPM tools and the results were process mapped to discover the differences between the laboratories. Following this process the analytical laboratories were reviewed for similarities and an optimum process was developed for the process going forward.

With the optimum process in place a gap analysis was developed and a forward implementation plan was crafted. Part of the solution was a total redesign of the analytical laboratory as well as an upgrade of the operating practices.

Outcome:

The result of the project was a vastly improved operating situation with reduced laboratory investigations and an improved level of productivity and operating efficiency.

CASE STUDY TWO

lab8

The Issue

A major specialty pharmaceutical and medical products manufacturer identified a need to improve inconsistent handling of service and complaint issues related to their marketed products. From both regulatory and business liability perspectives, it is critically important to pharmaceutical and medical device companies that they have robust and compliant drug safety monitoring processes. The company sought help from Groupe Athena to standardize and optimize their service and complaint handling process, while building an operating model and functional organizational structure to support their future growth objectives.

Their Approach

Groupe Athena provided consulting experience to augment the company’s internal Global Complaint Management team in the area of program support.

The Outcome

Groupe Athena formed an internal team at the client who was responsible for developing, maintaining, and integrating the program and working group plans, reporting progress to key decision makers, identifying and requesting additional resource requirements, and providing first-line quality assurance for program activities and deliverables.

Groupe Athena supported the team by developing and maintaining project plans, preparing agendas and updates, developing reference materials, facilitating and coordinating working sessions, documenting working group meeting progress and work products, assuring timely issue resolution, and assisting with the preparation of deliverables.

 

CASE STUDY THREE

An acquisition of a generic pharmaceutical company by a rival resulted in an order that required the divestiture of 3 products to a third party acquirer.

The responsibility of Groupe Athena was to act as the overseer for the divestiture to review: (1) the transfer of product, technology and marketing information, (2) the implementation of the technology by the acquiring company and (3) the subsequent verification that the client did not have access to the Confidential Business Information.

lab9

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 our 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 a 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 a client is 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 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.

FINANCIAL REPORTS

For Our Financials, please go to the following link: https://www.otcmarkets.com/stock/GATA/filings

Contact Groupe Athena, Inc. for assistance during any phase of the FDA approval or regulations process for companies seeking FDA approval on pharmaceuticals, medical products, and equipment or companies needing assistance to pass FDA inspection.

Company Name: Groupe Athena, Inc.
India Office:

10/234 Dadisheth Agiary Lane
Kalbadevi, Mumbai 400002

Toll free phone: 877-6GR-OUP6 or 877-647-6876
E-mail: info@groupeathena.com

RECENT NEWS

Groupe Athena, Inc. Reiterates Revenue Guidance Despite Currency Depreciation

May 24, 2016

OTC Disclosure & News Service

Mumbai, MHT, India –

Groupe Athena, Inc. announced today that the company is confident of meeting it’s projected revenue projections of $75 million in line with projections. The company also stated that it has an estimated $35 million of outstanding orders to provide a solid revenue base to build on for the 2017 fiscal period. 

The company stated that since over 92% of its orders are dollar denominated, the significant rupee depreciation over the past year would have minimal effect on revenues this fiscal year.

The Indian pharmaceutical industry is estimated to be over $55 Billion in 2020 and is expected to experience 8% annual growth through the end of the decade. GATA has emerged as a vital component of this growth by its ability to help Indian manufacturers get their products approved by the FDA for sales in the US. 

 

For more information on Groupe Athena, Inc. please go to www.otcmarkets.com/stock/GATA/quote or visit our corporate website at www.groupeathena.com.

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 marketing facility in India that currently employs 22 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

 

For more information contact:

Groupe Athena, Inc.

info@groupeathena.com

877-647-6876

 

Safe Harbor Statement

Certain statements set forth in this press release constitute “forward-looking statements.” Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words “estimate”, “project”, “intend”, “forecast”, “anticipate”, “plan”, “planning”, “expect”, “believe”, “will likely”, “should”, “could”, “would”, “may” or words or expressions of similar meaning. Such statements are not guarantees of future performance and are subject to risks and uncertainties that could cause the company’s actual results and financial position to differ materially from those included within the forward-looking statements. Forward-looking statements involve risks and uncertainties, including those relating to the Company’s ability to grow its business. Actual results may differ materially from the results predicted and reported results should not be considered as an indication of future performance. The potential risks and uncertainties include, among others, the Company’s limited operating history, the limited financial resources, domestic or global economic conditions — activities of competitors and the presence of new or additional competition and conditions of equity markets. 

GROUPE ATHENA, INC. POSTS STRONG 3RD QUARTER RESULTS

Apr 11, 2016

OTC Disclosure & News Service

Mumbai, MHT, India –

Groupe Athena, Inc. (Pink sheets GATA.PK) announced today   revenues of $15,162,114 for the period ending March 31, 2016.  Operating income before depreciation, amortization and taxes were $2,063,959 while net income increased an impressive 52.89% compared to the corresponding period in 2015, to $1,640,944.

Total revenues for the 9 month period this fiscal year were $59,487,887 which is well on pace to meet or exceed the previously announced 12 month guidance. Net earnings for the same period were $4,773,269, approximately .10 per share.

Cash reserves in the form of short term investments and deposits are extremely healthy and the Company’s backlog of orders is larger than ever and growing 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 22 consultants and is working towards aggressively expanding its presence in the Indian pharmaceutical industry. The Company’s web address is www.groupeathena.com.

To review the complete quarterly report please go to http://www.otcmarkets.com/stock/GATA/filings and click on “Filings & Disclosure”.

For more information contact:

Groupe Athena, Inc.

info@groupeathena.com

877-647-6876

 

Safe Harbor Statement

Certain statements set forth in this press release constitute “forward-looking statements.” Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words “estimate”, “project”, “intend”, “forecast”, “anticipate”, “plan”, “planning”, “expect”, “believe”, “will likely”, “should”, “could”, “would”, “may” or words or expressions of similar meaning. Such statements are not guarantees of future performance and are subject to risks and uncertainties that could cause the company’s actual results and financial position to differ materially from those included within the forward-looking statements. Forward-looking statements involve risks and uncertainties, including those relating to the Company’s ability to grow its business. Actual results may differ materially from the results predicted and reported results should not be considered as an indication of future performance. The potential risks and uncertainties include, among others, the Company’s limited operating history, the limited financial resources, domestic or global economic conditions — activities of competitors and the presence of new or additional competition and conditions of equity markets. 

Groupe Athena, Inc. Provides Guidance on Current Orders, Sets Release Date for 3rd Quarter Financials

Apr 05, 2016

OTC Disclosure & News Service

Mumbai, MHT, India –

Groupe Athena, Inc. announced today they are currently processing $64 million in customer orders and they are hopeful that this number will increase in the near term.  Based on the orders in hand the company expects to be able to convert at least one half or approximately $32 million into revenue during the current fiscal year ending June 30, 2016. This would put total current year revenue projections at $75,500,000, in line with projections and provide a solid revenue base to build on for the 2017 fiscal period.

The company has set the date of April 11, before the market open, for the release of 3rd quarter financials.

The Indian pharmaceutical industry is estimated to be over $55 Billion in 2020 and is expected to experience 8% annual growth through the end of the decade. GATA has emerged as a vital component of this growth by its ability to help Indian manufacturers get their products approved by the FDA for sales in the US. 

For more information on Groupe Athena, Inc. please go to www.otcmarkets.com/stock/GATA/quote or visit our corporate website at www.groupeathena.com.

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 marketing facility in India that currently employs 22 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

 

For more information contact:

Groupe Athena, Inc.

info@groupeathena.com

877-647-6876

 

Safe Harbor Statement

Certain statements set forth in this press release constitute “forward-looking statements.” Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words “estimate”, “project”, “intend”, “forecast”, “anticipate”, “plan”, “planning”, “expect”, “believe”, “will likely”, “should”, “could”, “would”, “may” or words or expressions of similar meaning. Such statements are not guarantees of future performance and are subject to risks and uncertainties that could cause the company’s actual results and financial position to differ materially from those included within the forward-looking statements. Forward-looking statements involve risks and uncertainties, including those relating to the Company’s ability to grow its business. Actual results may differ materially from the results predicted and reported results should not be considered as an indication of future performance. The potential risks and uncertainties include, among others, the Company’s limited operating history, the limited financial resources, domestic or global economic conditions — activities of competitors and the presence of new or additional competition and conditions of equity markets. 

GROUPE ATHENA, INC. POSTS 2nd QUARTER RESULTS

Feb 12, 2016

OTC Disclosure & News Service

Mumbai, MHT, India –

Groupe Athena, Inc. (Pink sheets GATA.PK) today announced revenues of $21,652,865 for the period ending December 31, 2015, an increase of $2,647,436 over the same period in 2014. Operating income before Depreciation and Amortization was $3,422,866 and reflects a Research and Development charge of $376,542. Net income for the period was $2,532,884 or $.05 per share.

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 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.

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 marketing facility in India that employs 22 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.

To review the complete quarterly report please go to www.otcmarkets.com/stock/GATA/quote and click on “Financials”.

 

Safe Harbor Statement

Certain statements set forth in this press release constitute “forward-looking statements.” Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words “estimate”, “project”, “intend”, “forecast”, “anticipate”, “plan”, “planning”, “expect”, “believe”, “will likely”, “should”, “could”, “would”, “may” or words or expressions of similar meaning. Such statements are not guarantees of future performance and are subject to risks and uncertainties that could cause the company’s actual results and financial position to differ materially from those included within the forward-looking statements. Forward-looking statements involve risks and uncertainties, including those relating to the Company’s ability to grow its business. Actual results may differ materially from the results predicted and reported results should not be considered as an indication of future performance. The potential risks and uncertainties include, among others, the Company’s limited operating history, the limited financial resources, domestic or global economic conditions — activities of competitors and the presence of new or additional competition and conditions of equity markets.

 

 

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