Regulatory Intelligence
Regulatory intelligence in the pharmaceutical industry refers to the process of continuously monitoring and analyzing regulatory developments and changes that may impact a pharmaceutical company’s operations and business strategies. This involves collecting, analyzing and synthesizing information from a variety of sources, such as regulatory agencies, industry associations, and academic journals, to provide companies with up-to-date and accurate information about relevant regulatory policies, guidelines, and requirements.
The goal of regulatory intelligence is to help companies stay informed about changes in the regulatory landscape and make informed decisions about product development, marketing and regulatory strategy. This helps companies stay ahead of the curve and minimize the risks associated with regulatory non-compliance.
With over 15+ years experience, our Regulatory Affairs team has helped several pharma and medical device companies by providing our regulatory intelligence services to:
- Formulate clinical development strategy that is aligned to regulatory expectations
- Evaluate clinical trials feasibility as per latest regulatory guidelines
- Take informed decisions during mergers and accquistions
- Avoid getting agency warning letters for issues related to non-compliance
- Simplify reguatory lifecycle management for different types of medical products
- Always meet regulatory timelines with proactive planning
Our Regulatory Intelligence Services
Regulatory Advisory
Provide strategic guidance to sponsor representatives for fulfilling regulatory obligations during new market entry, mergers, and accquistions.
Regulatory Submissions
Our RA Professionals can provide consulting and regulatory documentation services to sponsor team members for completing timely submissions.
Regulatory Management
We can prepare a comprehensive regulatory strategy for MAHs to comply with GCP, GLP and GMP regulations to get faster approvals for commercialization.