Apyx Helps Emerging Biotech Submit its first Marketing Application
Challenge
A specialty biopharmaceutical company engaged in developing pharmaceutical products that target unmet medical needs in specialty niche medical markets selected Apyx to help it with the submission of its first Marketing Application.
Solution
Apyx provided comprehensive submission project management and planning services to various internal project team members as well as several external CROs to ensure that all parties met their respective commitments.
Apyx also provided submission strategy guidance and proactively addressed document and submission-level issues before they threatened quality or timelines.
Lastly, we handled all document and submission-level publishing activity including scanning, cleaning image files, bookmarking, hyperlinking, and applying the correct PDF settings and QC. We assumed full responsibility for formatting every document being included in the submission and for the submission as a whole. Managing the process included frequent daily communication with the client and third parties on issue resolution until each document was fully approved for both content and format.
Results
The result of Apyx’s strategic planning and project management services was that the act of final submission compilation was a minimal project event. The submission was transmitted on time via the electronic submissions gateway (ESG) and accepted by FDA for review.
eCTD “On the Job Training”
Challenge
A top 20 global pharmaceutical company that specializes in the development and production of generic and proprietary branded pharmaceuticals needed to make a multinational electronic submission to FDA, Health Canada and EMEA. However, the company had not allowed sufficient time in their project planning to accommodate all the activities required to prepare a marketing application targeted for simultaneous submission to three health authorities.
A secondary goal of the client was to build internal electronic submission capabilities within their Regulatory Operations department.
Solution
Apyx developed and managed the client’s multinational submission strategy including maximizing document reusability across the three dossiers.
Apyx also provided strategic guidance and knowledge transfer to the client to help it build internal electronic submission capabilities including overall submission strategy, eCTD strategy, document standards, SOPs, eCTD technical publishing and more.
Results
All three submissions were completed on time and provided to the appropriate agencies within a 30-day window.
Additionally, the client now has an internal group fully capable of building multi-national electronic submissions. Apyx continues to provide support services and strategic guidance to the company as needed to complement its internal resources and expertise.
On Demand Support Services for Large Global Pharma
Challenge
Several large pharma clients require on demand support services from Apyx for a spectrum of activities including overall strategy and eCTD submission consulting, submission project management, strategic counsel on electronic document standards and paper and electronic document preparation and scanning.
Solution
Apyx has provided support services for over 200 submissions for large pharma clients and has processed more than 1,000 documents, meeting or exceeding timelines in every instance.
We provide our large pharma clients flexibility, accessibility, accountability and consistently high quality services. We always work hard to exceed expectations with even those clients for whom we have worked for many years.
Results
We measure our success with a 100% client satisfaction rate. The large pharma we have worked with remain Apyx clients today and serve as references as we continue to grow.
Document Management & Document Migration
Challenge
A mid-sized pharma needed a development partner to assist in progressing their lead product candidate through mid-stage clinical development. However, their lack of document organization internally was making it difficult to locate and provide the necessary documents required for review on a timely basis. In some cases, the correct version of a document could not be located at all.
Solution
Apyx implemented a document management system for the client to collect product intelligence from disparate company locations in which it resided--paper, dozens of unrestricted folders on a file share, and multiple individual hard drives--into a single controlled EDMS. Apyx also helped identify and classify the information and documents the client needed and import them into the EDMS with a dual manual and automated strategy.
Results
All critical product intelligence was captured in a single location with the appropriate technical and process controls in place, enabling the successful out-licensing of the product candidate.
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Case Studies
Learn more about representative projects and challenges that large and small pharma face in the area of regulatory submissions and how Apyx has helped meet these challenges.