Aquila Solutions, LLC Announces Availability of The Online eCTD Timeline Calculator

Online eCTD calculator pulls back the curtain on sequence submission planning.

2013-05-16

ATLANTA, GA, May 16, 2013 (Press-News.org) Today in Atlanta, GA, Aquila Solutions, LLC announced the immediate availability of The Online eCTD Timeline Calculator, enabling customers and prospects the opportunity to have free access to high level eCTD project planning expertise online, a first in the electronic publishing arena.

Joshua Boutwell, President and CEO of Aquila Solutions said, "We are pleased that our expertise in eCTD project planning and publishing is now available to everyone. We hope this timeline calculator will help sponsors plan their projects and save them time and resources."

Positive Customer Impact

Customers and prospects have already benefited from utilizing The Online eCTD Timeline Calculator in their current projects. The Online eCTD Timeline Calculator asks a series basic and non-sensitive questions to approximate the size and structure of the final eCTD sequence. It then calculates the number of man-hours necessary to process the gigabytes of data and create a valid eCTD. With Aquila Solutions online calculator, regulatory managers across the globe are no longer in the dark as to the resources they will need for publishing their eCTD submissions. In January of 2013, the FDA released a draft guidance stating the eCTD will be mandatory for all approved applications in 2015 and all development applications in 2016. At that time paper will no longer be accepted and eCTD will be the only approved standard.

Founded in 2011, Aquila Solutions, LLC is a worldwide leader in eCTD Electronic Regulatory Publishing Services. The company offers a wide range of products and services provides finalized documents to deliver a submission ready eCTD. For small sequences, under 1,000 pages and 20 documents, Aquila will provide deliverables according to a standard timeline. For larger sequences Aquila assists as needed with the development of a submission plan and project milestones to speed the publishing process. This includes submission through Aquila's FDA ESG account if requested.

Website: http://www.aquilasolutions.us

ELSE PRESS RELEASES FROM THIS DATE:

Untangling the tree of life

2013-05-15

These days, phylogeneticists – experts who painstakingly map the complex branches of the tree of life – suffer from an embarrassment of riches. The genomics revolution has given them mountains of DNA data that they can sift through to reconstruct the evolutionary history that connects all living beings. But the unprecedented quantity has also caused a serious problem: The trees produced by a number of well-supported studies have come to contradictory conclusions. "It has become common for top-notch studies to report genealogies that strongly contradict each other in where ...

Comorbidities should be factor in prostate biopsy choice, UCI study finds

2013-05-15

UC Irvine Health urologists and health policy experts report in a new study that two written assessments that identify existing comorbidities – the patient-reported Total Illness Burden Index for Prostate Cancer (TIBI-Cap) and the physician-reported Charlson Comorbidity Index – can successfully target prostate patients who would not benefit from biopsy to discover possible cancer. The authors say that by taking comorbidities into factor, it may not be necessary for men to have prostate biopsy. This study does not preclude the use of PSA screening, but it does set the ...

Seekers of past Honduran, Mexican civilizations to speak Wednesday, 15 May, at Meeting of Americas

2013-05-15

Cancún, Mexico -- A high-tech archeological exploration team of scientists and a filmmaker, who announced a year ago that they had glimpsed remnants of what might be a fabled ancient city in the Honduran rain forests, plans to speak about the team's discoveries here tomorrow (15 May) at the 2013 Meeting of the Americas, and to show previously undisclosed images of apparent archeological sites. A 7-page article in last week's The New Yorker magazine by Douglas Preston set the stage for tomorrow's discussion of the Honduras venture and other similar explorations. The article ...

UCLA study shows warming in central China greater than most climate models indicated

2013-05-15

Temperatures in central China are 10 to 14 degrees Fahrenheit hotter today than they were 20,000 years ago, during the last ice age, UCLA researchers report — an increase two to four times greater than many scientists previously thought. The findings, published today in the early online edition of the journal Proceedings of the National Academy of Sciences, could help researchers develop more accurate models of past climate change and better predict such changes in the future. "Previously, we could only infer temperature on land through changes in climate archives ...

Collecting DNA for human rights: How to help while safeguarding privacy

2013-05-15

DNA databases might help identify victims of crime and human trafficking, but how do we safeguard the personal privacy of innocent victims and family members? A new report online May 15 in the Cell Press journal Trends in Genetics identifies a number of key challenges to consider as experts develop such programs. Identifying victims of human trafficking remains a challenge around the world; between 12 million and 27 million individuals are currently enslaved. "If ever there is a justifiable use of DNA, it is the protection of victims of human rights violations and human ...

Hot on the TRAIL of graft vs. host disease

2013-05-15

For patients with leukemia and other hematological malignancies, transplantation of hematopoietic stem cells (HSCT) can be a powerfully effective therapy. In addition to the desirable anti-tumor effect, transplanted cells can also attack the host tissue, resulting in graft-versus-host disease (GVHD). In this issue of the Journal of Clinical Investigation, Arnab Ghosh and colleagues at Memorial Sloan-Kettering Cancer Center found that expression of a protein that causes cell death, TRAIL, in transplanted cells was critical for an effective anti-tumor response. Immune cells ...

Researchers identify signals that direct the immune system to reject a transplanted organ

2013-05-15

Organ transplant rejection occurs when the transplant recipient's immune system identifies the transplanted organ as foreign tissue and attacks it. It was previously thought that T cells, the immune cells that mediate rejection, must first be activated by molecules known as chemokines in order to migrate to the transplanted organ. In this issue of the Journal of Clinical Investigation, Fadi Lakkis and colleagues at the University of Pittsburgh used mice to demonstrate that chemokine stimulation of T cells is not required for migration. Instead, these cells must come into ...

JCI early table of contents for May 15, 2013

2013-05-15

Hot on the TRAIL of graft vs. host disease For patients with leukemia and other hematological malignancies, transplantation of hematopoietic stem cells (HSCT) can be a powerfully effective therapy. In addition to the desirable anti-tumor effect, transplanted cells can also attack the host tissue, resulting in graft-versus-host disease (GVHD). In this issue of the Journal of Clinical Investigation, Arnab Ghosh and colleagues at Memorial Sloan-Kettering Cancer Center found that expression of a protein that causes cell death, TRAIL, in transplanted cells was critical for ...

Major advance provides human embryonic stem cells for personalized medicine

2013-05-15

VIDEO: Human ESCs generated from SCNT embryos were capable of differentiating into a variety of cell and tissue types including contracting heart cells. Click here for more information. Somatic cell nuclear transfer (SCNT) is a technique in which the nucleus of a donor cell is transferred to an egg cell whose nucleus has been removed, generating embryos that are almost an identical genetic match to the donor individual. For the first time, a team of scientists has used ...

Long-term use of prescription painkillers for back pain linked to erectile dysfunction in men

2013-05-15

PORTLAND, Ore., May 15, 2013 – Regularly taking prescription painkillers, also known as opioids, is associated with a higher risk of erectile dysfunction (ED) in men, according to a study published online today in the journal Spine. The researchers included more than 11,000 men with back pain in the study and examined their health records to find out if men taking prescription painkillers were more likely to also receive prescriptions for testosterone replacement or ED medications. More than 19 percent of men who took high-dose opioids for at least four months also ...

Korea University College of Medicine successfully concludes the 2025 Lee Jong-Wook Fellowship on Infectious Disease Specialists Program

Girls are happiest at school – for good reasons

Researchers from the University of Maryland School of Medicine discover genetic ancestry is a critical component of assessing head and neck cancerous tumors

Heart damage is common after an operation and often goes unnoticed, but patients who see a cardiologist may be less likely to die or suffer heart disease as a result

The Lancet: AI-supported mammography screening results in fewer aggressive and advanced breast cancers, finds full results from first randomized controlled trial

Aquila Solutions, LLC Announces Availability of The Online eCTD Timeline Calculator

ELSE PRESS RELEASES FROM THIS DATE:

LAST 30 PRESS RELEASES: