Part of US based
Semler Group of Companies,
in business since 1946


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Regulatory Services

At SRC, our regulatory team along with a worldwide network of regulatory experts is focused on providing you with sound regulatory strategies in a complex and dynamic environment. We provide support throughout the product lifecycle, from defining the regulatory strategy, facilitating meetings and discussions with the authorities, to clinical trial approvals, marketing authorization submissions through post-licensing support.

SRC helps large, mid-sized, small & virtual bio-pharmaceutical, device and stem cell companies with regulatory advice and support at critical stages of their product development life-cycle. Our regulatory insight pans over 50+ years of exposure to US FDA, EMEA, EU, DCGI and other regulatory bodies to help you navigate the complex journey of global and local regulatory pathways from defining the regulatory strategy, facilitating discussions with the authorities, to clinical trial approvals, marketing authorization submissions and post-licensing support. We create in-depth regulatory plans that take into account protocol design, data, risk factors, timelines and other aspects that impact your product’s expedient and safe path to market.

If you are planning on conducting a study partially or completely in India, SRC can help you clear bureaucratic and development hurdles adeptly and proficiently. Unlike other CROs in India, regulatory processes are managed by the top management at SRC through direct & frequent interactions with the office of the DCGI to mitigate time delays, pre-empt queries and proactively engage with the regulatory body for mutual benefit.

Expert regulatory support for:

  • ANDA submissions
  • Early and late-phase studies
  • Biosimilars
  • Stem cell therapies
  • Medical devices
  • Launch and post-approval activities



About This Service

SRC offers comprehensive Phase I-IV services for drugs, devices & diagnostics.  The team is well-entrenched in regulated market requirements & GCP. Our collective goal is to shrink your time-to-market through superior scientific expertise and trial management innovation.