Semler Research Centre, a subsidiary of Semler Group, US is strengthening its presence in the country in formulation development (FD) and clinical research (BA/BE). As part of its strategy, it is looking at organic and inorganic growth routes.

In the inorganic route, the company has already initiated discussions with an Europe-based company of a similar fit for an acquisition.

Organic growth plans include beefing up its formulation development and clinical research services to small and mid-sized companies in regulatory consulting among others. Efforts are on to increase business opportunities in South Africa for BA/BE studies, GMP and QC/QA where an office will be opened soon.

In Bangalore, Semler has a full-fledged formulation development centre and a 48 bed clinical research unit at Salem. The company has been able to capture a substantial number of its orders from large pharma in the country. In-house expertise and time line deliveries have been the key strengths to bag the business. “We have a steady flow of orders which keep the facility in full capacity and boosting our outlook for 2010,” Gurudatta GG director and chief operating officer, Semler Research Centre Pvt. Ltd told Pharmabiz.

In October 2009, for pre-clinical assignments Semler inked an agreement with Notox, Netherlands. It provides Pharma Engineering Solutions to leading companies through the New Delhi-based cGMP Pharma plan.

Semler has already undertaken several projects for companies in the US and Europe in formulation development. Its team of scientists work between India and US on pharmaceutical development.

Currently Semler capability spans total pharma solutions that cover formulation development (Pre, Formulation and Stability), Preclinical, clinical trials, bio-analytical service with over 200 methods, GMP & QA consulting.

In the next six to eight months, the company will focus on clinical monitoring services for phase-II to phase-IV studies, biostatistics, safety management, medical writing, regulatory affairs, dossier preparation and submission of ANDA’s NDA, DMF Type II and DMF Type III.

It may be noted that Semler’s consultancy arm provides services to many multinational pharma companies in India to set up GMP units. The company plans to expand the service to companies in Europe and US. It has assisted a leading pharma major in Karnataka for six WHO submissions.

The parent company Semler which has business operations in telecom and defence equipment entered into pharma services in India because of availability scientific personnel, dependable talent pool for swift turnaround with assignments and highest number of USFDA plants outside the US. “India is recognized as a hub for CRAMS and clinical trials with dependable quality standards. Semler Research which commenced its India operations in 2006 is confident to grow business from formulation development, BA/BE studies dossier development and consulting,” stated Gurudatta.