Putting Science to Work

Regulatory services

Clinical Management Data & Biostatistics

Syngene's Clinical Data Management and Biostatistics team provides solutions that are customized to meet the specific needs of each clinical study. Our systems, SOPs and project personnel are equipped to provide cost-effective and secure services. Based on previous experience of dealing with the complexities of global regulatory requirements, our project teams have developed the expertise to deliver projects on time while adhering to sponsor and protocol specific requirements.

Syngene's comprehensive disaster recovery plan is designed to keep its extensive information system intact and ensure continuity of research projects in the event of a disaster/adverse event.

Syngene offers CDMB services to support:

  • BA/BE studies 
  • Phase I-IV clinical trials 
  • CMC programs
  • Preclinical development (In vivo)

Data Management:

  • Case Report Forms (CRF) design 
  • Workflow management 
  • Data capture
  • Double data capture
  • Electronic data capture 
  • Discrepancy/query management 
  • Medical coding 
  • Serious adverse event reconciliation 

Biostatistics:

  • Statistical inputs for protocol design 
  • Sample size calculation 
  • Randomization/blinding
  • SAS coding
  • Statistical analysis 
  • Statistical report preparation
  • Support DSMB/DSRB conduct an interim analysis
Regulatory Services

Syngene provides regulatory services to facilitate all stages (phases I-IV) of drug development. We accomplish this by providing interdisciplinary strategy planning to arrive at the most effective and efficient pathway towards regulatory authorizations. To date, we have achieved 100% success in obtaining regulatory approvals. By leveraging the extensive experience and learnings from multiple engagements, Syngene's regulatory services team is able to effectively handle a wide variety of regulatory challenges and helps sponsors meet exigent timelines. We have the ability to provide services as complete study management and/or as customized services. 

Syngene’s expertise in regulatory services spans the following areas:

  • New chemical entities 
  • New biological entities 
  • Generics / biosimilars (rDNA products) 
  • Monoclonal antibodies 
  • Medical devices 

Syngene’s range of regulatory services includes:

  • Compiling regulatory dossiers including CTD and eCTD format
  • Obtaining regulatory approvals for :

    • Phases I-IV clinical trials including new indications and special population studies
    • Conducting BA/BE studies
  • Obtaining export NOC for biological samples for testing 
  • Obtaining import licenses for drugs 
  • Performing safety reporting 
  • Registering products for marketing approval 
  • Forming strategies for global CTD and eCTD regulatory submissions that conform to US FDA and ICH guidelines 

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