Regulatory Services

Regulatory Services from Research to Commercialization

Regulatory Affairs

Regulatory Affairs services play a vital role in ensuring the successful development and commercialization of drugs as they navigate the complex and ever-changing landscape of global health authorities.

Our Regulatory Affairs services consultants work with the life science customer to understand and manage the demanding complexity of the diverse Regulatory requirements in order to successfully launch their products in new markets and maximize their market value.

Submission Forecast and Planning
Submission Document Management and Tracking
Regulatory Content Management
Change Control Management
Label Change Tracking & Integrated Regulatory Information
Regulatory Intelligence & Reporting and Analytics

RnD Solutions

We help our clients  make a meaningful impact on patients’ lives by combining new science and human ingenuity with leading-edge technology.

Regulatory Strategies & Consulting

Identify your proposed product’s attributes by assessing its design, use, and performance regulatory implications
After successfully determining your product’s attributes, establish what prevailing regulatory precedents are likely to influence your regulatory strategy. Remember that even in the absence of a product that raises similar issues as yours, some analogous products, even those outside your specialty, can inform your regulatory strategy
Viability After drafting your regulatory strategy and documenting all the major assumptions and risks, invite the internal stakeholder team to ensure that the strategy mirrors the project’s goals and the product’s attributes
Reduce the risk of non-compliance issues, and associated impact on share value & sales
Improve control & measurement capability to provide justification for further resources if/when needed

Publishing & Submissions

Global eCTD Publishing and Submissions With a comprehensive knowledge of global eCTD publishing trends and submission formats (for example, eCTD/Non-eCTD electronic submissions [NeeS])

Developing and maintaining the process of capturing and documenting the regional Health Authority (HA) requirements.
Paper to Non-eCTD electronic submissions (NeeS) to eCTD conversions.
Periodic training and updates on the ever-changing global eCTD Publishing and Submission Regulatory requirements.
Gap analysis to create the process aids, charts, etc.
Periodic quality check for effective time management.
Detailed tracker creation to track all the version changes made through the eCTD publishing lifecycle.
CSR -Report Level Publishing
Drug Master FIle Submissions
AI Powered Publishing Automation

End -To-End