The global Life Sciences and Pharmaceutical industry are going through a major paradigm shift. With organizations increasingly focusing on being patient-centric and providing improved quality of care as opposed to healthcare providers and drug manufacturing – they need to adapt to the newer technological advancements that enable them to do so.
Orion facilitates this technology innovation for some of the pioneers and leaders in Life Sciences and Pharmaceutical industry to realign businesses and manage regulatory process efficiently – making them cost-effective and accessible.
Our ReALM® GRIP Solution
Regulatory Strategy and Planning activities in pharmaceuticals and medical device companies are currently made of a number of disjointed sets of tasks using spreadsheets or siloed technology capabilities, introducing a number of inefficiencies during the upstream phases of the regulatory value chain, resulting in downstream delays, significant re-work, missed opportunities and potential loss of revenues.
Our ReALM Global Regulatory Intelligence and Planning (GRIP) is a set of Cloud-based solutions providing a structured and repeatable process to access regulatory guidelines, subject matter interpretations and industry best practices for different types of regulatory activities and submissions across the globe along with the ability to create actionable component-level plans using standardized templates. The ability to go from regulatory strategy to checklists to actionable plans is unique to ReALM, which existing solutions do not address today. We strongly believe that access to regulations, templates and plans all in a single, subscription-based solution greatly improves efficiencies and reduces total cost of ownership due to the availability of all strategy and planning related items in one repository. We would be glad to arrange for a demo.
- Global repository of regulatory requirements
- Requirements checklist generation
- Submissions planning and preparation
Regulatory Submission Planning
- Lightweight planning capability, easy to use
- Assign team members to tasks
- Create project schedules
- Export to MS-Project or Excel
Enable regulatory strategy and planning activities by providing an integrated, authoritative, globally accessible, reference repository of regulatory requirements to enable effective submissions planning:
- Regulatory Requirements
- Submissions Requirements
(INDs, NDAs, BLAs, PSUR/DSUR, GVD, others.)
- Submission review
- Lifecycle Management Requirements
- Inspection, Labeling Stability Requirements
- Subject Matter Expertise/Industry Best Practices
- Company Specific Experiences
- High-Level Checklists/Granular Requirements
- Cross-Sectional Views of Requirements
- Submission Publishing Templates
- Submissions Planning
Our ReALM® IDMP Solution
The European Medicines Agency (EMA) is gearing up towards the implementation of the ISO Identification of Medicinal Products (IDMP) with a target deadline for full implementation in 2018 for medicinal products.
IDMP poses several challenges to the pharmaceutical industry, the key being the ability to integrate disparate data from multiple systems managed by multiple functional areas within an organization. While being a technology and an integration challenge, IDMP also poses organizational and political challenges given that it requires the collaboration and cooperation among many functional units, which have been traditionally independent and siloed for a long time.
Most importantly, most of the information is embedded in documents such as Summary of Product Characteristics (SmPCs), CMC documents, cover letters, electronic application forms, etc. Extracting data from documents is going to be a major challenge.