Welcome to the Q3 issue of FREYRFOREWORD!
A quarterly round-up of the latest happenings and updates from Freyr.
|The scope of healthcare industry in emerging markets spanning countries in Latin America, Asia Pacific, Africa and Middle East is interesting when compared to the developed markets which include the US, Western Europe, Japan and recently included Organisation for Economic Co-operation and Development (OECD) countries Brazil, Russia, India.|
|Road Blocks & Challenges
|Most of these countries rely upon Certificate of Pharmaceutical Product (COPP/CPPs) when they import drug products. The CPP was originally introduced by World Health Organisation (WHO) to support undersized Medicines Regulatory Authorities without a Quality Assurance (QA) facility.
Technical Challenges & Possible Solutions
To encourage harmonization of regulations between agencies of both developed and emerging markets the following issues have to be addressed.
|Global Product Development
May be hampered owing to varying requirements of regulations for different countries. This can be minimised if various regulatory agencies initiate participation from the very beginning.
Global Stability Program
A demanding task due the fact that different countries fall into different temperature zones can be countered effectively if requirements of all markets that are targeted can be taken early on. Another suggested approach is to have batches on stability at both real time and accelerated conditions.
Global Clinical Trials
Ever since the introduction of ‘Kefauver-Harris’ amendments to FD &C act post thalidomide tragedy in the United States, drug development has been revolutionized compelling the manufacturers to demonstrate their drugs to be both safe and effective. The list of countries which want a clinical trial to be performed in their own populace has been on rise which made the industry to include patients from varying ethnicities and nationalities in their global clinical trial programs.
Using same packing inventory within that particular region, pharmaceutical firms can achieve harmonization. This in turn will help companies when regulatory agencies within that particular region achieve harmonization in the labeling needs. Pre-submission meetings unlike the developed markets, the absence of presubmission meetings or meetings for scientific advice will lead to issues after submissions are completed. The agencies and experts from industry should work to address technical concerns both at product developmental level and clinical study/bio-equivalence study level.
|Developing a global protocol for clinical trials as a part of product development is arduous but can be beneficial in advancing towards more globalization. Until now clinical data from US/EU is widely being used to gain approval in Asian markets, this situation may soon change where agencies in developed markets would also be presented with data from emerging markets like Asia by companies to justify their findings.In conclusion, emerging markets present a huge opportunity for the pharmaceutical companies looking for registering their products despite the challenges. This can also be seen as a move towards achieving global harmonization for a right reason.|
|As an organization, we at Freyr, have always placed the highest value on our business associations and partnerships. It has been our guiding principle to identify newer opportunities and create exceptional engagement excellence for our clients that transform into long term relationships. As always, it is a great pleasure to announce the New Wins of this quarter.|
|Freyr wins a UDI Compliance Project with
BSD Medical CorpFreyr has been chosen as a solutions partner by BSD Medical Corp, a leading US-based medical device company, specializing in manufacturing hyperthermia systems for cancer treatment.Freyr will provide end-to-end UDI compliance solution and support for BSD Medical Corp to meet the fast approaching deadline for GUDID submissions.Freyr will deploy “Freyr IDENTITY”, it’s indigenous UDI compliance solution application, to streamline, collate, compile and validate all the respective GUDID attributes and enable smoother and error-free submission. Additionally, Freyr IDENTITY will enable an efficient UDI compliance Lifecycle Management System through its advanced Data Tracking, Management, Validation and Automated GUDID Submission functions.
|Strategic Regulatory Submission Project for Top 20 Pharmaceutical Company
Freyr has been selected for a large regulatory submission project by a Global Top 20 Pharmaceutical company. The project will entail end-to-end services for regulatory submissions.
Artwork and Labeling Project for Top Global Manufacturer of Alternative Medical Products
Freyr has been awarded a global artwork and labeling project by a Top Global manufacturer of natural homeopathic remedies. This offshore project will see Freyr’s artwork and labeling CoE function involved in creation of artwork and labels for the client’s portfolio of products which will be marketed in multiple geographies.
|Submissions Publishing Services for Top 5 Global Pharmaceutical Company
Freyr has been engaged as a regulatory service provider of choice for a Top 5 multi-national pharmaceutical company for two consecutive regulatory service undertakings.Nine publishing associates will be deployed on-site at the client location to provide submissions publishing services including global submissions activity to FDA, EMA, LATAM and ROW in various formats (eCTD, NeeS, paper) and regulatory services for global eCTD submissions.
|Biopharma Client Graces Freyr Office in US
The Chief Medical Officer (CMO) of an US based biopharmaceutical drug development company visited Freyr’s office in the last quarter. The CMO met with Freyr management and sales team and conversed about emerging trends and service models in the regulatory space. The team also discussed about Freyr’s regulatory submission expertise and its proprietary tools EVMPD, rDMS, and Freyr Submit (eCTD). Freyr looks forward in supporting the bio-pharma company in their regulatory needs.
|A Top-20 Global Pharma Client Visits Freyr Premises
In the current quarter, Freyr was honored by the visit of a high profile Regulatory Affairs and Operations delegation from a Top-20, Global Pharma/Nutraceuticals Company at its office in Cranbury, NJ, USA. The delegation comprised of directors, managers and other staff from the customer’s Regulatory Affairs and Operations vertical met with Freyr’s core group of program managers, delivery managers, subject matter experts and project teams.The client thanked and recognized Freyr’s contribution towards the successful completion of a critical NDA submission. The project is significant as it is one of the largest submissions undertaken by the company, aided by Freyr. The client also talked about future opportunities and valued the partnership with Freyr, thus ensuring continued support from Freyr for their regulatory needs.
|Freyr completed the addition of a new 450 capacity facility to its Global Development & Operations Centre in India.As part of the global expansion plan, the new facility will complement Freyr’s strategic Business Acceleration Program that has recently won the company several global accounts with Top Pharma & Life Sciences companies.
Freyr is entering a new growth phase by expanding its operations base and augmenting its vision to be a global leader in the Regulatory Solutions and Services domain. The new facility is slated to enhance and increase Freyr’s delivery capabilities in key areas aligned to the future growth plans.
Mr. Sudheer Sagar, VP Operations said, “Addition of the new facility was on the cards as part of our FY plan for 2014. Earlier in the year we had set into motion an
|aggressive plan to augment our Global Regulatory workforce with an aim to increase our Regulatory Affairs capabilities and enrich the engagement experience for our recently acquired new accounts. The workforce increase was scheduled to coincide with Freyr’s facility expansion plans.We are now well-poised to handle the growth and the new facility will allow us to further improve our operations and effectively support our new accounts at the current pace of growth”.
Freyr’s new facility will increases the Regulatory Workforce by over 20% and will serve as a strategic global delivery hub for Freyr’s Regulatory CoEs and R&D Services workforce that has been earmarked to globally deliver a wide range of services in the Regulatory Affairs, Regulatory Operations, Regulatory Intelligence and Regulatory Information Management areas.
|Freyr launches Freyr IDENTITY:
The Accurate, Efficient and Faster UDI Compliance SolutionFreyr IDENTITY is the latest addition to Freyr’s growing Regulatory Software Solutions portfolio and is aimed at enabling medical device companies successfully navigate through the UDI compliance landscape.Suitable for a company of any size with any number of devices, Freyr IDENTITY is exclusively designed to streamline the complete compliance process by connecting disparate internal functions and integrating data sources and formatted information with a centralized database for automated XML generation and submission that meets all the FDA regulated UDI mandates.Freyr IDENTITY ensures reliable regulatory compliance with GxP practice, 21 CFR Part 11 including additional compliance capabilities like Version control, Validation, XML Conversion based on SPL and HL7 protocols, as well as Publishing and Printing to enable accurate, efficient and faster UDI compliance.
|Freyr IDENTITY is differentiated with its advance architecture and unique features.
Freyr IDENTITY takes up all the inherent challenges of medical device manufacturers and provides an effective and streamlined solution to meet the complex UDI Compliance requirements efficiently.
The client, a global top 20 pharmaceutical company, required round the clock support for its critical and strategic NDA submission which targets schizophrenia. Freyr was also engaged to provide support for the client’s clinical study reports (CSR) projects.
The client followed multiple highly complex processes for the NDA submission project which had multiple stakeholders spread across the geography. The NDA submission (size ~76 GB) comprised of 1.5 million pages with 5,314 files, 937 folders, 300K bookmarks and 2.3 million hyperlinks.
Operational/quality/challenges with existing vendor had delayed delivery timelines impacting the client’s submission timelines. Existing vendor also had technology issues (viz. ad-hoc network downtimes, system failures and performance issues) with existing publishing and document management systems, Citrix and overall LAN network. The client also faced issues with the existing vendor for delivery of high priority CSRs, who took six months to deliver each report, affecting stringent delivery dates.
Freyr developed a strategic delivery model; established an account level PMO and an onsite program manager to manage individual projects; created a well-defined project plan; defined aggressive and objective performance parameters; deployed intelligent project budget tracking; created a communication campaign plan using innovative progress trackers and metrics to complete overview of real time project progress status. Freyr team used effective onsite-offshore model and was able to help the client deliver the submission ahead of the planned submission deadline.
Freyr helped the client submit critical NDA submission ahead of the planned timelines with zero defect quality. Overall Freyr team took ~6100 man hours over three different projects.
LARGEST NDA SUBMISSION
Clinical Study Report