Catch up with the latest at Lotus Labs – as and when it happens. Featured here are updates on news and events. Read on…
26/05/2011
Lotus Labs first Indian CRO to be awarded the prestigious "International Leadership Star for Quality Award - 2011"
Lotus Labs first Indian CRO to be awarded the prestigious "International Leadership Star for Quality Award - 2011"
Lotus Labs received the prestigious “International Leadership Star for Quality Award” in the Gold category recently in Paris for its outstanding business achievements, for perseverance and leadership in excellence, and quality in accordance with the QC 100 TQM (Total Quality Management) criteria.
The international B.I.D. Quality Award is awarded on the basis of commitments to the criteria outlined in the QC100 TQM, which serves as a guideline to business leaders in the improvement of process and systems. The TQM is an organization approach to consumer satisfaction involving customers, people, and the continuous improvement of processes.
B.I.D. is currently the most important private organization in the world presenting a Quality Award on the basis of principles as solid as those of the Deming in Japan (only for Japanese companies), the Baldrige in the U.S. (only for U.S. companies), or the EFQM in Europe (only for European companies). B.I.D. is professionally related with companies in different countries whose products and services help position them as leaders whom invest in innovation, technology, training and installations. For more information visit – www.bid-org.com

05/01/2011
Phase 1 Study for Injectable Malaria Vaccine
Phase 1 Study for Injectable Malaria Vaccine
Lotus Labs is conducting a first-in-human dose escalating study on healthy volunteers at its Phase 1 clinical pharmacology site. The injectable malaria vaccine is a recombinant multi-antigen vaccine and is being administered to 45 healthy volunteers’ to assess and evaluate the safety and immunogenicity profiles associated with the drug, with a follow-up period of one year. The Phase 1 study is being sponsored by ICGEB (International Centre for Genetic Engineering and Biotechnology, New Delhi, India) through an overseas vaccine initiative that commenced in August 2010.
05/01/2011
CAP and NABL Certification renewed
CAP and NABL Certification renewed
MDS has been accredited by NABL since 2006 in accordance with the international standard ISO 15189, subsequently re inspected and granted continuation of accreditation. The lab was accredited by CAP in 2008 and has successfully completed the re inspection in 2010.
22/12/2010
Regulatory Audits in 2010
Regulatory Audits in 2010
22/12/2010
FDA submission - study on topical retinoid for acne vulgaris
FDA submission - study on topical retinoid for acne vulgaris
Lotus completed FDA submission study on topical retinoid for acne vulgaris in early 2010 for an international sponsor. Study was a multicentre, double blind, randomized, vehicle controlled, parallel group study in 1150 patients with mild to moderate acne vulgaris conducted at 31 different sites across India.
The second FDA submission study for a US based sponsor, conducted on a topical drug combination of an antibiotic and retinoid for acne vulgaris has just been completed in December 2010. Study was a multicentre, double blind, randomized, vehicle controlled, parallel group study in 1100 patients with mild to moderate acne vulgaris conducted at 57 different sites across India.