Since it started in 1999, NICE’s technology appraisals have reached over 80% approval of drugs (including recommended and optimised) and 6% of treatments have been approved for research only.  The recommendations are based on the effectiveness of the treatment compared with competitors treatments already available on the NHS.

The MHRA is collating examples of best practice in patient information design. We are pleased to anounce that one of the Patient Information Leaflets tested by Cambreg has been nominated as PIL of the month by the MHRA. Congratulations to our Clients and to the Cambreg team.

(23-MAY-10) CambReg MD, Karen James, is attending the “Doing business in Hong Kong and South China” UKTI seminar on 24th June 2010 – Millennium Grandstand, Newmarket Racecourse.

CambReg compile eCTD dossiers using LORENZ software, one of the most comprehensive and up to date eCTD software. In June 2010, the LORENZ eCTD Review System has been selected by the European Directorate for the Quality of Medicine and Healthcare (EDQM) for the management of its electronic applications.

The EDQM has taken the step as part of ongoing efforts to shorten the processing time of applications for the certificates and ensure adherence to deadlines. Companies approaching EDQM for certificates of suitability can no longer make changes to submitted dossiers once the assessment process has begun…. Link

With an increasingly challenging and complex regulatory environment there has never been a more critical time to have the highest possible standards in Pharmacovigilance (PV). Cambreg can now deliver a PV service tailored to your specific needs, from Periodic Safety Update Report preparation through to providing your PV department in its entirety. We provide 24 hour PV hotline, Qualified Person and Deputy QPPV for PV in EU, Expedited reporting capabilities across EU member states, Signal detection reviews, Medical Information services as well as writing Risk Management Plans. We have highly skilled PV staff with a detailed knowledge and expertise in dealing with EU Competent Authorities. Our aim is to identify and manage safety issues that may emerge after licensing and to protect your product in the market by providing an EU PV service to existing and new customers, from within Europe and overseas.

For Further information on our PV services please call + 44 (0) 1480 465 755 or email info@cambreg.co.uk

Cambridge Regulatory Services Directors Dr Mike James and Mrs Karen James are visiting India from the 4Th-9Th February 2010 to attend the wedding ceremony of the Business Development Director from Siro Clinpharm.

Surabhi Melmane one of CambReg’s Regulatory Project Managers will be in Mumbai, India this week attending the Clinical Trial Congress at the Marriott from 20th to 21st January. Please contact Lisa Tietjen at CambReg if you or any one in your company wants to meet up with her before, during or after the congress.

Karen James, MD of Cambridge Regulatory Services Ltd. and Dr Chetan Tamhankar, COO of SIRO Clinpharm

Cambridge,UK, 14th September 2009
Cambridge Regulatory Services (CambReg) is pleased to announce the formation of a strategic alliance with SIRO Clinpharm, a leading global Indian based Clinical Research Organisation. The new alliance will provide benefits to pharma companies in both Asiaand Europe. CambReg’s regulatory expertise, coupled with SIRO’s abilities to conduct fast paced trials, will provide clients with a one-stop, cost effective solution for all their registration needs.
“Having come highly recommended to CambReg by the Mumbai High Commission, we are extremely pleased to be endorsing this alliance with SIRO today,” commented Karen James, Managing Director of Cambridge Regulatory Services. “This partnership will provide European pharma companies with increased confidence in accessing cost effective clinical trial solutions, hence introducing new clients to SIRO. In return SIRO will have the benefit of offering regulatory expertise through CamReg.”
“Our alliance with CambReg would go a long way in helping small and mid-sized 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.
The new alliance will offer full regulatory services to pharma companies wishing to register human medicines, including new small molecule or biotech entities, Biologics, Herbals and Generics. Services include preparing Clinical Trial Applications, Marketing Authorisation Applications in eCTD format, specialist Paediatric Investigation Plans and Paediatric Use Marketing Authorisations, as well as managing Decentralised and Mutual Recognition Procedures across the whole of the European Union.

Ansar Momin joined CambReg’s Project Managers Team at the beginning of September. Having previously worked for Baxter, Wockhardt and Gen Pharma he brings over six years regulatory experience to CambReg. His areas of expertise are generics and eCTD submissions.
Mid September Kim Philpott joined CambReg’s Regulatory Support Group as Applications Administrator. Kim is much needed to cope with the increase in demand for eCTD work. Kim experience in running the body shop for a prestige car dealership has taught her to stay calm under pressure. Just what she will need with Regulatory deadlines looming.