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:4/28/2016)... April 28, 2016 Oramed Pharmaceuticals Inc. ... pharmaceutical company focused on the development of oral drug delivery ... upcoming PIONEERS 2016 conference, presented by Joseph Gunnar ... New York . Nadav Kidron , ... conference. Presentation Details:   PIONEERS ...
(Date:4/27/2016)... -- Hologic, Inc. (Nasdaq: HOLX ) announced ... second quarter ended March 26, 2016.  GAAP diluted ... and non-GAAP diluted EPS of $0.47 increased 14.6%.  ... reported basis, and 6.3% on a constant currency ... quarter, highlighted by 14.6% growth in non-GAAP EPS," ...
(Date:4/27/2016)... York , April 27, 2016 ... report titled, "Skincare Devices Market - Global Industry Analysis, ... According to the report, the global skincare devices market ... is anticipated to expand at a CAGR of 10.1% ... in 2023. Browse the full Skincare Devices Market ...
Breaking Medicine Technology:
(Date:4/29/2016)... ... April 29, 2016 , ... Coast Dental Fort Stewart ... at its new location in the Exchange Furniture Mall at 112 Vilseck Road in ... 50-inch Samsung Smart TV. Plus attendees will have the opportunity to meet general dentists ...
(Date:4/29/2016)... ... April 29, 2016 , ... The Wharton ... $30,000 Perlman Grand Prize of the 2016 Wharton Business Plan Competition —as ... People’s Choice Award, and the Committee Award for Most ‘Wow Factor,’ making them ...
(Date:4/29/2016)... ... April 29, 2016 , ... The Gluten-Free Certification Program ... to announce the launch of the GFCP Scoop in response to ... purpose of the GFCP Scoop site is to keep the gluten-free ...
(Date:4/29/2016)... ... April 29, 2016 , ... New York City based oral and maxillofacial surgeon Dr. ... very effective way to treat obstructive sleep apnea. Dr. Jamali is proud to offer this ... procedure that involves one or both jaw bones. This surgery is performed to correct the ...
(Date:4/29/2016)... ... April 29, 2016 , ... Jvion, the ... of funding led by Eastside Partners, with participation from existing investor Martin Ventures. ... base and accelerate its technology and product roadmap. , “Jvion is ...
Breaking Medicine News(10 mins):