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.
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