Navigation Links
SIRO Clinpharm and CambReg Ltd Strategic Alliance to Offer Regulatory Services in Europe
Date:8/25/2009

MUMBAI, India and CAMBRIDGE, England, Aug. 25 /PRNewswire/ -- SIRO Clinpharm, a leading Indian MNC CRO, and CambReg Regulatory Services, a UK-based pan-European regulatory services provider, announced today the formation of an exclusive strategic alliance to help companies register their products in the European market.

Unlike the US, Europe is a patchwork of small to medium-sized markets with varying regulatory and economic barriers to entry, including a requirement to register new generic drugs in each EU country. Many EU regulators also require small clinical trials called bridging studies to be conducted before marketing approval is granted. These two factors make the introduction of generic and other products in Europe a complex affair.

"Our alliance with CambReg will go a long way in helping small and midsized companies cut through the regulatory maze in Europe," said Dr. Chetan Tamhankar, Chief Operating Officer of SIRO Clinpharm. "This alliance builds on the strength of our European clinical trial operations and allows us to offer greater value to our clients," he added.

Commenting on the alliance, Karen James, Managing Director of CambReg said, "Often companies have to look for multiple vendors to register their products in Europe. CambReg's Pan - European regulatory expertise coupled with SIRO's abilities to conduct fast paced trials in Europe will provide clients with a one-stop and cost effective solution for their European registration needs."

The alliance will offer full scope regulatory services to companies wishing to register human medicines of any kind including new small molecule or biotech entities, Biologics and Herbals as well as Generics. Services include preparing CTAs, MAAs in eCTD format, PIPs, PUMAs, etc and managing DCP/MRP across the EU as well as consultancy for any issues with regulatory authorities.

About SIRO:

SIRO Clinpharm Private Limited (SIRO) is among one of the leading global Clinical Research Organizations (CROs), offering full scope services and conducting clinical trials in the Pharmaceutical, Biotechnology and Medical Devices sectors in compliance with international standards. SIRO is one of the first CROs founded in India, which caters to the needs of pharmaceutical companies across the world. The company has offices in India, USA, Israel and in Europe in Germany, Romania, Estonia and Greece. SIRO has recently opened offices in the Czech Republic and Spain. More information about SIRO is available at www.siroclinpharm.com.

About CambReg:

CambReg, established in 1999, is a full service regulatory services company based in Cambridgeshire, UK. It assists pharmaceutical and biopharmaceutical companies with regulatory affairs advice, submissions and compliance. It has provided services to over 200 clients based in Europe, America and Asian countries. The founder directors are ex- health authority staff and have over three decades of experience with European regulatory affairs. CambReg has Investors In People status in the UK. More information about CambReg is available at www.cambreg.co.uk .


'/>"/>
SOURCE SIRO Clinpharm
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. SIRO Clinpharm Completes Successful Implementation of Oracle Life Sciences Application Suite
2. General Wesley Clark Joins Immtech as Consulting Strategic Advisor
3. Strategic Diagnostics Launches Initial Oncology-Targeted Antibody Reagent Catalog
4. StatSure Signs Strategic Financing and License Deals with Inverness Medical Innovations
5. Replidyne Provides Strategic Update
6. IDM Pharma Provides Update of Product Pipeline and Announces Plans to Evaluate Strategic Alternatives for the Company
7. TorreyPines Therapeutics Announces Strategic Plan with Focus on Clinical Development Activities to Maximize Value of Versatile Lead Compounds
8. Encorium Announces the Initiation of a Strategic Partnership With Prologue Research After the Postponement of Negotiations Regarding Its Planned Acquisition; Strategic Reorganization and Cost Reduction Plan Initiated as Strategic Alternatives are Investig
9. Vermillion Renews Strategic Alliance Agreement With Quest Diagnostics, Inc.
10. Isogen Retains Strategic Partner Sheridan Road Financial to Meet Global Biopharma Demand
11. ExonHit Therapeutics Expands Strategic Collaboration With Allergan
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/24/2017)... , March 24, 2017  GenomeDx Biosciences today announced ... Database) and Decipher® Prostate Cancer Classifier tests will be ... of Urology (EAU) Congress held March 24 to 28, ... Annual EAU Congress is Europe,s ... research in the urological field. The abstract ...
(Date:3/24/2017)... GENEVA , March 24, 2017 /PRNewswire/ ... Day revitalizes efforts to develop sutezolid as effective response ... Tuberculosis Day, TB Alliance and the Medicines Patent Pool ... of sutezolid, an antibiotic drug candidate which demonstrated encouraging ... development of sutezolid in combination with other TB drugs ...
(Date:3/23/2017)... Research and Markets has announced the addition ... Replacement Procedure By Technique, Repair Procedure By Technique, By Region, By ... ... forecasted to grow at a CAGR of 13.35% during 2016-2021 ... rising aging population, growth in population with heart disease and rising ...
Breaking Medicine Technology:
(Date:3/24/2017)... ... March 24, 2017 , ... Infectious ... to hospitals in the United States, it’s a threat that is constantly changing ... facing infection prevention and offers strategies for the healthcare community to help decrease ...
(Date:3/24/2017)... ... March 24, 2017 , ... The Radiology Business ... Awards . The annual awards, now in their 12th year, are among the most ... winners. , In 2016, the awards were retooled to recognize achievements in both large ...
(Date:3/24/2017)... San Antonio, TX (PRWEB) , ... March 24, 2017 , ... ... a new clinic which can be found at 9618 Huebner Road. The clinic is ... Thobaben, PT, OCS, Clinic Director, and Dr. Ali Higgins, PT, will provide care from ...
(Date:3/24/2017)... , ... March 24, 2017 , ... ... planning, and related services to families and business owners across eastern Michigan, is ... feeding regional families struggling with financial difficulties. , The Oxford/Orion FISH Food Pantry ...
(Date:3/24/2017)... ... 24, 2017 , ... In just two days, Aqua Design ... garden on Kickstarter . Surpassing the $100,000 milestone so quickly,10-times the original ... (and counting) already backing the campaign. , “We are very grateful for ...
Breaking Medicine News(10 mins):