INTERNATIONAL REGULATORY AFFAIRS

Regulatory & Product Development  Services 

Synapse has multi-dimensional and Multimodal specialisations as per the International  Business Approach .The Core Competency of Synapse also remains in intrinsic knowledge of Registration requirements  across the Globe 

BE/BA STUDIES /CLINICAL TRAILS

We have 23+ years of successful registration expertise and experience and have registered over 200 + product registrations in 30 Countries globally .We along with our CRO (Contract research Organisation) have expertise in New product development process where in concurrence with active PD we can offer the regulated country approved BE/BA and CT ( Clinical Trials )  studies . Compilation of  CTD , ECTD dossiers for submissions & DMF preparation is also actively served for both API and finished formulation for manufacturing companies in preparing and supporting the ECTD submissions and DMF submissions 

CTD/ECTD/ANDA/DOSSIER COMPILATION :

We are actively involved in offering customised solutions where the manufacturing facility stability chambers are occupied and line of products are to be put in for Stability Studies and AMV  by Offering its CRO and LAB sites for conducting the SS & Analytical support studies . We are also responsible for the complete  ECTD, CTD , ACTD , ANDA submissions and responding all submissions along with continuous MOH regulatory queries initiation and concluding to final approvals for registration for its manufacturing partners 

AUDITS/INSPECTIONS/BATCH MANUFACTURING CHECKS / - ACCESS TO EUROPE FOR MANUFACTURING COMPANIES

We also can create without notice surprise Audits and Inspection on manufacturing site for Overseas Contract Manufacturing or Licensing companies for their Indian Manufacturing Partner operations . We also are involved in EU APPROVALS FOR MFG FACILITIES with our association of EU agency where we conduct - pre inspections and all supporting services to initiate EU &PICS actual audits . We  have a perfect setup for the manufacturing partners from getting Inspected , Audited and approved for EU &PICS along with the ready distribution network partner in All of Europe .

MOH INSPECTIONS /AUDITS

We Also Assist to Manufacturing Plants in getting MOH approvals audits along with ready Distributor Partners -

PRODUCT DEVELOPMENT /R&D PROJECTS

We have Independent Product Development and Research laboratories for Enhancement of existing product features and specifications and also we have capabilities to perform Product Development for Pharmaceuticals with DSIR Approved (Government of India ) laboratories . Currently we are developing products with nano Technology and Liposomal Formulations in Product development .