Freyr Solutions

Artwork Centralization Process Webinar - Freyr Solutions This webinar will give you insights on Artwork centralization and its impact, importance and implementation approaches to effectively address product recalls and counterfeiting. Time: November 28 th , 2017 Date: 9:30 AM EST | 5:30 PM GST | 2:30 PM UK Duration: 1 Hour 30 Minutes Register Your Spot

Elemental impurity risk assessment     idmp software      udi compliance      electronic trial master file (etmf)     Regulatory Intelligence services   Regulatory Labeling services   Regulatory Document Management System (RDMS)     ectd software services     Regional Regulatory Services

Smarter the eCTD publishing software, smoother will be the eCTD submissions process. But to ensure the smoother submissions, life sciences organizations must consider the wide variety of documentation they need to manage.  The entire documentation Lifecycle covers a complete clinical and preclinical research data accumulated over the years. In addition, region-specific submission requirements (across the USA, the European Union, Canada, GCC, Saudi Arabia, Oman, South Africa, Switzerland, Australia, New Zealand, Bosnia & Herzegovina, and Thailand) vary depending on the respective Health authority (HA) regulations and, thus the submission templates and formats. Likewise, as organizations move towards fulfilling their submission obligations, either DMF or baseline submissions, under strict compliance timelines, they face increasing complexities to efficiently manage different eCTD templates / formats across the entire submission lifecycle. Some of the major challenges fac...

Freyr rDMS  is an end-to-end electronic Regulatory Document Management system exclusively designed to enable Regulatory Groups and Departments within a life sciences organization to seamlessly create, capture, manage, organize, connect, deliver and archive regulatory data and documents in a compliant, efficient and intuitive manner. While traditional Document Management Software Solutions are typically retrofit for regulatory needs, Freyr Regulatory Document Management Software is built ground-up, keeping specific nuances and expectations of regulatory strategies and operation functions in mind. Our solution combines an end-to-end set of features spanning the whole document lifecycle from inception and authoring up to submission and archiving of regulatory documents. With capabilities to efficiently handle enterprise-wide content and ease of integration with legacy systems, Freyr rDMS provides an integrated platform to address the critical need for knowledge sharing across th...

Freyr INSIGHT  is Freyr’s Regulatory Intelligence Enterprise Platform, which gathers and analyzes publicly available regulatory information. This includes communicating the worldwide reach of regulations, pharmaceutical updates using a system, and monitoring the current regulations, guidance, policy, and legislation. Regulatory Intelligence

Overview In an ever changing Regulatory environment, Regulatory authorities around the world mandate drug companies with various Drug labeling formats and standards. To comply with those time-critical labeling mandates, organizations find it challenging to create, track and manage various aspects of drug labeling lifecycle. Major challenges organizations face include: Management of various activities involved in the labeling process like review and approval work-flow Collaboration between global and regional teams Core to regional/national label alignment Change control and deviation management Quick and effective label changes based on new guidelines or drug updates Tracking and compliance At that time, ineffective tracking could result in high risk of mislabeling and counterfeit drugs leading to product recalls affecting overall finances of the organization. In such adversities, labelers look to implement a centralized label lifecycle management solution for structured ...

Overview Audit & Inspection readiness – The first and foremost aspect every pharma company / a CRO should consider is the Trial Master File (TMF) audit & inspection readiness. With stacks of essential electronic / paper-based clinical trial documents to be sourced, tracked and managed, the biggest setback companies could face is to allow reconstruction of the trial that confirms the quality of data produced. Therefore it is of paramount importance that these documents are filed, indexed, and archived in a way that they can be easily retrieved and available for inspectors to give insight about that trail. In addition to that, increasing complexity of clinical trials, procedural costs and redundancies with generation of essential documents may delay the approval of medicines to reach the market. This way, industry has come across a need for centralized eTMF solution which not only acts as centralized repository of all documents but also reduces costs includ...