Regulatory Information Management
Regulatory Information Management (RIM) in the pharma industry refers to the processes, systems, and tools used by sponsors, MAHs and medical device manufacturers to manage regulatory information and ensure compliance with relevant regulations. This can include a range of activities, such as collecting, organizing, storing, and updating information about regulations, submitting regulatory reports and documents, and tracking changes to regulatory requirements. The goal of RIM is to help organizations stay informed about the regulations that apply to them and maintain compliance, while also reducing the risk of errors and fines.
How We Help Clients with RIM
- Provide strategic guidance to sponsors for seeking pre-market and post-market approvals
- Streamline regulatory operations through digitalization that enables faster preparation of regulatory documentation
- Implement lean regulatory processes and establish proactive compliance overight through measurable KPIs
- Applying latest methods in scientific research
- Leveraging latest technology for content creation
- Always meeting timelines and avoiding delays
Our Regulatory Information Management Services
Product Information Management
Product Registrations Management
Technical Dossier Management
Labelling & Packaging Operations
REGULATORY INFORMATION MANAGEMENT
Regulatory Intelligence & Strategy
Health Authority Interactions
Regulatory Change Management
Regulatory Records Keeping
Your Questions & Our Answers
> Keeping up with changing regulations and ensure that their RIM processes are up-to-date.
> Managing the compilation and storage of regulatory documents, submissions, and reports in multiple formats.
> Ensuring data quality across regulatory operations to eliminate risks, minimize errors and avoid non-compliance findings.
> Having a robust RIMS that integrates with quality management systems, document management systems, and compliance management platforms.
> Ensuring data privacy and security of confidential business information across processes and digital assets
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.
