Semler Research Center

SRC is a full service driven CRO located in Bangalore with expertise in all areas of Clinical Research and Drug Development, including Formulation Development, GxP consultation, Audits, Dossier Preparation, Regulatory Services, Quality Assurance and Medical Writing. We have conducted studies for various regulatory authorities like WHO, USFDA, MHRA and DCGI.

SRC has been developing products for US and Indian markets. Three ANDAs have been successfully submitted and few are under various stages of bio (including patient and healthy volunteer studies). We have developed formulations on oral solids, ophthalmics, topical applications that includes ointments and creams, specialized formulations that includes transdermals, liposomes and few injectables. Our current project also includes 505 b(2) products and some new platforms to improvise delivery of existing drugs. We are managing about 10 ongoing end to end integrated projects with International customers from North America, Europe, Latin America and South Africa.

We also provide complete range of service offerings in GxP consultancy with over 28 full time consultants. They are currently working with global companies to set up the facility and in this note we have successfully cleared 21 regulatory audits ( USFDA, MHRA, WHO, MCC & Korean FDA).

Recently, our infrastructure for clinical, report writing and bio-analytical was audited by WHO and we have successfully cleared it for two of our sponsors (04 products). We have submitted 6 FDA studies and as per plan we will facilitate in submitting about 25 studies by the end of this fiscal year. Moreover we have completed 2 studies for EU submission and about 4 studies are scheduled to be submitted before March. We have slotted submission studies for MHRA and MCC in the month of February. You may be aware that we have commissioned a 80 bed new BA/BE facility at Bangalore with this we have over 128 bed capacity. In the last 9 months, we have dosed over 2000 volunteers and analysed over 60000 samples covering about 7 to 8 customers. We have developed over 200 methods in plasma , urine, whole blood and aqueous humor covering wide therapeutic areas.