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.
Your Questions & Our Answers
There are two types of service models that your company can choose from:
Medical Writing FSP Model: Our team will take the responsibility of managing all medical writing activities for a complete clinical program or for an individual study with a cost-effective pricing structure.
Dedicated Resoucing Model: We can have specialized resources allocated for your organization to hand-hold all types of medical writing needs for a fixed duration.
We use the best of technology platforms that helps us to deliver our medical writing services through continous real-time collaboration with sponsors. Following are some of the systems we use:
Compier Medical Writing Platform: This is our proprietary 100% digital content management platform that facilitates rapid content authoring, completing real-time collaborative review and allows continous content lifecycle management. specifically for rapidly processing soft such as Microsoft Word to create documents.
Reference management software: Our Medical writers use reference management software such as EndNote, Mendeley, or Zotero to manage and organize their references.
Content management systems: If sponsors want us to use content management systems (CMS) like Veeva Vault, Documentum or Sharepoint, our team is familar with how to store and manage documents, track versions, and facilitate collaboration between different team members.
Typesetting software: Medical writers use typesetting software such as LaTeX or InDesign to create well-formatted documents, such as scientific publications and regulatory documents.
Medical Terminology software: Medical writers use medical terminology software such as SNOMED, ICD-10, or MedDRA to ensure accurate and consistent use of medical terms.
With the use of advanced technology and quality-driven processes, our medical writing team members collaborate with Biostatistics, Medical Affairs, Drug Safety and Clinical Data Management teams to deliver accurate and purposeful publications and other medical content with a quick turnaround with 100% compliance to global regulatory requirements. Every medical writing project is meticulously managed and delivered with stringent scientific, statistical, editorial and quality control review.
