Groupe Athena Inc. - GATA

About Us
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. Our 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 Groupe Athena 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, 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



Case Studies

Case Study 1:
A 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 2:
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.

Our 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 3:
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.
 

Website: www.groupeathena.com

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