Welcome to the October 2016 issue of FREYRFOREWORD!
A monthly round-up of the latest happenings and updates from Freyr.
Just into the third quarter, nothing more we could ask for. It’s time for celebrations at Freyr. The joy, the pride and most importantly the delighted feeling of being recognized for our commitment towards addressing the time-critical Regulatory challenges the global life sciences industry is facing today. We are pleased to share with you that Frost & Sullivan, a leading global strategy consulting company, headquartered in the US, recognized Freyr for its best practices in the Life Sciences Regulatory domain and presented us the “2016 India Knowledge Process Services for Life Sciences Growth Excellence Award.”
Frost & Sullivan recognizes outstanding industry achievements by presenting Best Practices Awards to companies that have demonstrated exemplary performance across various industries, commending the diligence, commitment, and innovative business strategies required to advance in the global marketplace. The award program acknowledges the companies that excel in their respective business segments and their efforts to improve the industry as a whole. Frost & Sullivan’s Knowledge Process Services for Pharmaceutical Life Sciences Growth Excellence award identifies companies that exhibit exemplary growth, attributed to enhanced solutions and superior service capabilities.
Presenting the award, the consulting firm expressed their views on why they have selected Freyr as:
Freyr has grown exceptionally in 2015, which reflects its capability to offer unique and customized solutions designed to address the regulatory domains such as generics, consumer healthcare, Drugs, Devices, Nutritional Supplements, Biologics, innovative, and therapeutic areas. The company’s performance is driven by the right blend of customer focus, intense competitive technology positioning, and its strategic partnership with top pharma and consumer healthcare companies.
“Given its strategic intent to provide end-to-end regulatory services across the entire value chain, supported by regulatory bodies, Freyr demonstrates a high growth rate in the pharma and life sciences industry. The company, with de-risked Centers of Excellences (CoEs) and with in-house specialized regulatory framework streamlines Regulatory procedures across the lifecycle and ensures the quality of the processes from an operational, subject-matter and technology perspectives.” - Shruti Jadhav, Manager - Best Practice Research, MENASA, Frost & Sullivan.
Aiming at Radically Redefining Global Regulatory Solutions and Services going forth, entire Freyr team is delighted to receive this award at the right time, which keeps us more rooted to our deliverables. Nothing more we could ask for than keeping our clients compliant enough.
The accelerated introduction of new regulations and guidelines for pharmaceutical labeling industry during past few decades, demands companies to be pro-active in terms of the implementation lifecycles. The dire consequences associated with the erroneous label on a drug or a medical device accounts for severe health risks for the patients. Physicians rely on the label instructions and integrity of the information on the label while prescribing to patients, which further makes it unavoidable for companies to roll out their products with inaccurate labels. However, with the changing landscape of labeling guidelines, released by major health authorities around the globe, the execution challenges emerge as major obstacles in the lifecycle. It further becomes a rigorous task when companies carry out their expansion plans and new geographies are involved. Let’s discuss some major challenges that companies generally stumble upon when it comes to global labeling management.
Collaboration between Global and Regional Teams
Business expansions are obvious in the pharmaceutical industry which in turn demands cross-functional coordination among the teams established across borders. Every geography demands distinct regulations to be followed by the manufacturers in order to make it easy for the regional end-users to understand the label instructions easily. In order to manage the language complexities, pertinent harmonization amid regional and global teams becomes fundamental.
Global labeling management is set on the foundation of huge volumes of drug and medical devices data scattered over a wide range of sources. Many times this information is distributed in unstructured files and formats which make it difficult for companies to pull out all the relevant information and consolidate it. Information stored at multiple sources further accounts to duplicate records mainly because of different regional versions available across different geographies. In other words, the “single source of truth” is missing here. Since the compilation process is an arduous activity mostly undertaken manually; the possibility of landing on error-prone end-results are quite high.
Incompetent Tracking Process
This activity commonly involves a robust technology in order to monitor the labeling lifecycle progress by tracking and maintaining the repository of products. Failing to deploy a robust global labeling management software solution, companies can witness ineffective tracking that could result in high risk of mislabeling and counterfeit drugs leading to product recalls, affecting overall finances of the organization.
Knock Over these Challenges with Freyr GLX Framework
A deep dive into the above mentioned segments include:
Freyr LABEL, an in-house centralized labeling lifecycle management solution, and as part of Freyr GLX Framework, streamlines end-to-end Regulatory labeling practice in a company of any size. Right from creation, tracking and managing Company Core Data Sheet (CCDS) deviations, CCDS updates, and developments to creating, implementing, and inspecting multi-lingual regional labels as well as custom reporting. Freyr LABEL puts companies in total control of all their regulatory labeling compliance needs to manage the complexity of Regulatory labeling (Core and regional) with a centralized label lifecycle management platform.
Do you know? The United States Food and Drug Administration (US FDA) has mandated that certain Regulatory submission types (NDA, BLA, and ANDA) should be filed in electronic Common Technical Document (eCTD) format beginning May 5, 2017. Also, Health Canada (HC) is considering to make eCTD format mandatory by 1st January 2018. As the drug makers across the world are waking up to the fact that they should do away with the legacy paper document submissions adhering to the HA regulations, let us give you a quick roadmap towards successful eCTD submissions.
eCTD – the definition and the purpose.
According to ICH, eCTD is an interface for industry to transfer regulatory information while facilitating creation, review, life cycle management and archiving of the electronic submissions. eCTD provides a harmonized technical solution to implement the Common Technical Document (CTD).
The main purpose of this technical solution is to make the Regulatory submissions easier with a common global standard enabled for all drug makers which indeed can streamline the Regulatory submissions to health authorities.
Countries accepting eCTD format
Now eCTD has become a global submissions format. The countries which are accepting eCTD submissions are:
Which applications should be in eCTD format?
As US FDA mandates drug makers who are willing to file the below applications should follow eCTD format:
For Health Canada, the following applications are considered to be mandatory for filing in eCTD format:
Why should you adopt eCTD?
To conclude, electronic submissions are the order of the day. However, Drug makers are not on the verge of deadlines. With a little time in hand, chalk out your region-wise eCTD submissions plan for faster drug approvals. Consult an exclusive Regulatory Submissions & Publishing partner.
Drug Master File (DMF) holds great importance in terms of information associated with several medical products regarding their chemical specifications, and manufacturing. The type IV DMF is associated with the material used in their preparation or as we call them excipients. Excipient DMF is submitted to FDA to support IND, NDA, ANDA, BLA, and other DMF. Let’s take a tour of the general guidance to prepare Excipient DMF as stated by “The International Pharmaceutical Excipient Council (IPEC) of the Americas”
Maintaining the DMF
DMF - New Submission
Amendment to Original Submission
Technical content of the DMF
Recommendations from FDA
Is recommended and any required binders should be used as per the DMF specified by FDA.
Characterization of the Excipient
Process Controls during Manufacturing and Packaging
Reference Standards for Materials
In order to ensure quality, safety, and efficacy of the medicines it is critical to maintain quality of the excipients. The drug formulations are influenced by excipients to a great extent due to which the API (active product ingredient) and drug products falling under categories of cosmetics also get impacted. For that reason, implementing GMP (Good Manufacturing Practice) standards and maintaining smooth CMC operations for the excipients becomes necessary.
For any Pharma or Life Sciences company involved in conducting clinical trials, maintaining / managing a Trial Master File (TMF) is inevitable. A decade ago, the master file enclosed heavy volumes of paper-based documents for majority of the clinical trials carried out. The only central location for these documents, supporting compliance requirements and good clinical practices, was a physical repository piled up with stacks of files. Such arrangement of documents led to discrepancies and inconsistencies in TMF in terms of file name, structure classification and information distribution among various stakeholders. Although there were companies that adopted an internal TMF structure that covers a better classification outline and content model for existing TMFs, it did not align with that of the TMF arrangement carried out by other clinical trial stakeholders in the industry.
To address the inconsistency in TMF structure, a source model was announced in 2010 that represented as a reference point for all clinical trial stakeholders in the industry. The new TMF model standardized document names, classification and descriptions that could be used commonly by majority of the stakeholders. It has been observed that companies utilizing electronic document management system for clinical trials witnessed higher degree of quality in clinical study, improved cost effectiveness and reduced timelines. Subsequently several pharma companies involved in clinical trials are eager to shift from huge volumes of paper-based CT documents to a centralized online mode of document management system.
Advantages for Pharma Companies Implementing eTMF Models
In the era that is evolving constantly, organizations tend to move faster and expect the exchange of documents in a snap of finger and the accessibility of information from anywhere, anytime. In this context, eTMF delivers advanced features of document management with high data security to manage clinical trial information. From a business value standpoint, companies using eTMF solutions can be benefited in following aspects:
High Quality of Documents
eTMF is an automated document management system. Thus it offers very minimal scope of errors in document management as compared to paper-based processes, handled manually.
Abridged Overall Cost
Implementation of eTMF helps reducing overall compliance overheads since the extra costs incurred in manual auditing and report generation are saved.
One of the major drawbacks with paper-based TMF management system is the difficulty in accessing a specific file remotely. eTMF eliminates these shortcomings and offers an easy and secured access for viewing, sharing, and retrieving any file from anywhere, anytime with customizable access levels.
What features should an effective eTMF solution entail?
While planning to integrate eTMF with their on-going practices, companies need to consider few key aspects that an eTMF solution should have. Following are some of the features /aspects they should look upon:
End-to-end TMF Process
When looking for an eTMF solution, consider a complete package that offers services right from set up to configuration to management to reporting and auditing of clinical trial documents. It should allow to create and index documents as per the agency’s TMF structure. Auditing is an essential element of a complete eTMF system, therefore the solution should also support internal and external audits in all aspects.
This aspect of an eTMF solution accounts for the performance and versatility in order to adapt to any kind of organization. A flexible solution should enable competency for both small and large clinical trials without disturbing the system performance.
In order to be suitable for every kind of infrastructure comprising clinical trial documents, the solution must be highly customizable. Features like advanced search options, user management controls, monitoring activities, categorizing of groups, etc. accounts to a customizable eTMF solution.
Remote accessibility is one of the prime features that an eTMF solution should have which enables companies to author, review and approve clinical trial documents and update global repository in real-time provided the solution is securely cloud-hosted. If an eTMF solution facilitates the cloud advantage, it will offer companies a comprehensive global access functionality.
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