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Registration of API & Formulation with DCGI in India
API, Formulation products and medical devices from foreign manufacturer to work as Indian Agents in India, providing following supports
Application review
Submission to DCGI office
Helping for completion of deficiencies form DCGI
Help for getting import permission
Office & local support for Marketing the product in India
Support for preparing application for registration purpose
Preparing & / or review of DCGI application (include POA, Schedule D(I) & (II), PMF, DMF in CTD format etc)
Out Sourcing of API, GMP compliance & Vendor audit
Helping to out sourcing for API, Formulation Products & Analytical activities for our Clients from Indian manufacturers
GMP audit to judge the actual GAP and / or GMP status of Vendors
Periodic GMP audits for existing suppliers
Synthesis & characterization of Reference test standard (Those are not available commercially)
Synthesis of Reference test materials on contractual basis
Complete Characterization & its data as per regulatory acceptance
Contract Research (Chemical Moiety) up to 1 Kilogram (Kilo Lab scale)
Chemical moiety synthesis on contractual basis in lab
Synthesis / preparation up to Kilogram level
   
 
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