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

Rain Agent Vaults: Revolutionizing Payments with AI

Innovative Payments with AI Power Alright, folks, Rain's gone and done something that's probably going to shake things up in the payments world—'cause they've given AI agents the ability to handle money like never before. We're not just talking about some run-of-the-mill integration here. This is a genuine game changer, promising to make agents as financially savvy as...

ProBio, AbTis Forge Bond for Next-Gen Oncology ADCs

Deal or No Deal: ProBio's New Licensing Agreement In the ever-evolving realm of biopharmaceuticals, ProBio's recent handshake with South Korea's AbTis is stirring the pot. The shot-callers at ProBio are passing the baton to AbTis, giving them a crack at developing a thumping new therapeutic antibody asset aimed squarely at oncology targets. Pretty slick move if you ask...

Alogent's Unify Snags Award for Innovation and Impact

Innovation That Captures Attention Alogent sure did grab the spotlight with their Unify platform walking away with a Credit Union Times Luminaries Award. The name of the game here is deposit processing innovation—the kind of buzz that turns heads in the banking world. This recognition isn't just another plaque for the lobby; it's a testament to a significant stamp on...

Sokolove Law Wins $28.8M Verdict for Misdiagnosis Case

Jury Awards $28.8 Million in Misdiagnosis Case Well, here's a tale that's bound to ruffle some feathers in the medical community—$28.8 million tossed on the table because an emergency room missed a life-threatening aortic aneurysm. For the uninitiated, this isn't just chump change; it's the cost of dropping the ball when the stakes are as high as a human life. A jury in...

FirstDigital Expands Fiber Network in Utah and Arizona

Weaving a Web of Connectivity Let's talk about FirstDigital putting its shoulder to the wheel in Utah and Arizona. They're expanding their redundant fiber network to rope in more businesses under their umbrella of connectivity. This ain't just another dry IT endeavor—it's about building a safety net for our ever-connected world. The Stakes of Network Disruption You know...

Jubilant Eyes MPN Breakthrough with JBI-802 Data at ASH

Presenting the Case for JBI-802 From the bustling circus of drug development, here comes Jubilant Therapeutics, strutting their stuff with JBI-802, a dual inhibitor designed to tackle myeloproliferative neoplasms (MPNs) with a one-two punch. Now, they're set to drop some spicy deets at the 68th ASH Annual Meeting in New Orleans this December. So what's the fuss about?...

Alyssa Bunch: Big Moves in Tennessee Real Estate

Navigating the Tennessee Real Estate Maze If you're talking about where the real estate action happens in Tennessee, you'd better mention Alyssa Bunch, the Vanderbilt-educated dynamo who turns the unforsale into the must-buy. Most of the deals she orchestrates are invisible to the public eye until they're all but written in ink and ready to reshape landscapes—or, more...

Bakersfield Sees Spike in Crashes Post Time Change

Evening Darkness and Safety Concerns Folks, it seems Bakersfield streets transform into a battlefield once the clock falls back. With darkness creeping in earlier, those evening hours right after the time change see a sobering uptick in accidents. According to an analysis by Chain | Cohn | Clark, pedestrian and bicyclist crashes from 5 to 7 p.m. double. It's not just...

IASO Bio's In Vivo CAR-T: A Game Changer for Oncology?

You ever feel like you're watching history happen right in front of you? That's the vibe with IASO Bio's latest move in the realm of oncology. This outfit just scored a major victory, getting China's NMPA and the U.S. FDA to greenlight their IASO208, a CD20-targeting in vivo CAR-T therapy. It's not every day you see a company land dual regulatory nods like...

Zephyr's Alto Hood: Redefining Kitchen Versatility

An Artist in the Kitchen Who knew a kitchen hood could be a canvas, right? Zephyr, always a punch above the ordinary in kitchen design, has pulled another rabbit out of their hat with the Alto Wall Custom Hood. Forget blending in; this piece is about standing out and shouting style—all while keeping your cooking area fresh. Options Galore The Alto Hood isn't about...