Your Trusted Partner for Navigating Compliance

For pharmaceutical and biotechnology industries, where regulation is stringent, a well-crafted regulatory strategy is vital for successful market introduction and managing global market intricacies. Our comprehensive service portfolio offers insights and solutions necessary to meet Global Regulatory standards, boost compliance, and ensure successful product approvals. By delivering tailored Regulatory Services, we empower organizations to confidently manage complex regulations and achieve smooth Regulatory Submission processes.

 

Specialized Expertise in Regulatory Operations

Our expertise also extends to specialized areas such as Regulatory Submission Services, where we ensure comprehensive documentation, efficient publishing, and timely filings. We offer strategic support in Clinical Trial Regulatory Affairs, aligning trial requirements with both regional and global compliance standards. Through advanced Regulatory Publishing solutions, we streamline submission formats and accelerate review timelines. Furthermore, our deep experience in regulatory oversight for clinical trials empowers sponsors to navigate evolving guidelines and expectations with precision and confidence.

  • Experince in Range of Products Medicine- Generic/Branded, Biologics, Combination Products, class I device)
  • In-House Team of Regulatory Experts and International Regulatory Contact Points
  • Associated with different clients across EU & USA Regions
  • Inhouse eCTD & SAS

Proven Track Record: Our Regulatory Expertise

280 +

MA Transfer Support

88

Annual Reports

430 +

eCTD Publishing

59

Safety Labelling Changes

3896

xEVMPD entries

Clinical Trials Regulatory Affairs

  • Regulatory Pathway Strategy
  • CT Application Submission (India, USA)
  • EU CTR/CTIS Submission (EU)
  • RPEV Representation
  • IND eCTD publishing
  • IND Gap Analysis & eCTD conversion

Request for Proposal

Ready to streamline your regulatory journey? Get in touch with us today to learn more about how we can support you in adhering to compliance.