GATA Investment Highlights

New Post Public Reply Private Reply Replies (0) Message Board

Aug 21, 2012 at 11:30 PM

GATA >> Investment Highlights

Record Revenues For Third Quarter and Nine Month Financials

$10M Third Quarter Revenue

Nine Month Revenues Over $34M

Cash on hand over $3.5M

Expected over $44M Annualized Revenue

Symbol is GATA
News Link: http://finance.yahoo.com/q?s=GATA&ql=1

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

GROUPE ATHENA, INC. FinancialsEDGAR Online Financials(Fri, Jul 6)
GROUPE ATHENA, INC. FinancialsEDGAR Online Financials(Wed, Jun 6)
» More Headlines for GATA

Newer

Older

Scroll down for more posts ▼

Top 10 Most Recent News Articles

PwC US and India Unite for Global Consultancy Powerhouse

Rearranging the Consultancy Chessboard Piling onto the game of consultancy realignments, PwC just made a move reminiscent of playing strategy poker. They're tossing together PwC US and PwC India's advisory capabilities for a new joint venture. It’s like pushing two puzzle pieces to make a single colorful picture that stretches from the U.S. all the way to the...

Tam-Peli Steps Up in SCLC Battle: Trial Insights

Noteworthy Developments in Small-Cell Lung Cancer Treatment Let's dive into a story straight from the world of small-cell lung cancer (SCLC) that doesn't take any prisoners. The antidote making waves is tambotatug pelitecan, or Tam-Peli for short, showcasing its might in the unrelenting fight against relapsed SCLC. The phase III TAISHAN-302 trial puts Tam-Peli...

First-Time Homeowners: Unseen Pitfalls of Insurance

Understanding Homeowners Insurance: Beyond the Basics Most folks diving into homeownership for the first time get caught up in the whirlwind of price tags, loans, and knick-knacks for their new place. Meanwhile, the nitty-gritty of homeowners insurance often gets tossed to the side. But take it from a weary watchdog of financial storms—it’s those details in the policy...

GORGIE Unleashes Berry Burst: Target's New Drink Star

GORGIE Targets Taste Buds with Berry Burst Ever feel like you're missing out on that energy drink everyone seems to be raving about? Well, GORGIE's out there making some noise again, and this time it's got a new punchy player in the game: Berry Burst. It's not just another drink; it's shaking things up in the energy aisle with its exclusive launch at Target. Modern style...

UWM Faces Class Action Deadline: Key Insights for Investors

The High Stakes Reality for UWM Investors If there's one thing that's certain in this jittery world of investing, it's that losses have a way of waking you up. Right now, anyone tied up with UWM Holdings Corporation (NYSE: UWMC) shares needs to keep their wits about them; we're barreling toward an October 13, 2026 deadline for a class action lawsuit. The clock's ticking...

Ris-Rez May Set New Standard in Relapsed SCLC

The Game-Changing Results Innovation in pharmaceuticals sometimes feels like a waiting game, but when a fresh breakthrough like this rolls in, it lights up the whole landscape. Risvutatug rezetecan, or Ris-Rez for short, has shown promising potential in the fight against relapsed small-cell lung cancer (SCLC) that has progressed after platinum-based therapy. Survival...

Regeneron Faces Legal Heat: Lead Plaintiff Deadline Looms

Regeneron’s Tight Spot: Legal Showdown Well, here we go again—Regeneron Pharmaceuticals (NASDAQ:REGN) is under some serious heat. If you're an investor who faced significant losses with this biotech juggernaut, remember that the clock’s ticking down to the wire. By tomorrow, September 14, 2026, you need to decide if you're going to throw your hat in the ring for...

MRI Surveillance Gains Ground in Lung Cancer Care

Shifting the Standard: MRI's Rise in SCLC Treatment Here's a twist that baffles the traditionalists—ditch the prophylactic cranial irradiation (PCI) and catch clearer days with MRI surveillance for small-cell lung cancer (SCLC). The latest international phase III MAVERICK trial might just redraw the lines on what's considered standard care in this relentless disease....

Trial Disappointment: No Significant Gains in NSCLC

Dissecting the Nuances of the EVOKE-03/KEYNOTE-D46 Trial Every once in a while, we come across a trial that rattles cages in the research community. Today, it's the EVOKE-03/KEYNOTE-D46 trial, a collision of hope and hard-knock reality. This Phase 3 trial, which sought to explore the potential combo of sacituzumab govitecan (SG) and pembrolizumab on metastatic non-small...

PANDAG G1 Debuts: Revolutionizing Lawn Care Efficiency

The Future of Landscaping Unveiled Get this—PANDAG is set to shake things up at GaLaBau 2026 with their futuristic G1 autonomous mower. This isn't just another piece of lawn equipment; it's practically a tech marvel on wheels, weaving together LiDAR, AI Vision, RTK, and 4G tech to make it the ultimate multitasker for the landscaping industry. We're talking obstacle...