Process Consulting
Apyx's regulatory strategies and consulting services are designed to help pharma and biotech companies plan for and create high quality submissions to the FDA and international regulatory authorities and learn how to effectively integrate the requirements and advantages of eCTD into the document creation process.
We will work with you to develop a process and strategy that integrates the creation, capture, review and approval of discovery and development information with final submission requirements.
Pharma and biotech companies increasingly see the value of viewing eCTD as a process rather than an end goal, and are working with Apyx early in the process in anticipation of eventual compound licensing or company/product candidate acquisition to add market value by having study documents submission ready.
We also advise on the future direction of electronic submissions: eCTD, Regulated Project Submissions (RPS), the Document Reference Model (DRM) and other mature and emerging standards.
Technology Evaluation
We have first hand experience working with most leading industry products as well as extensive knowledge of best of breed functionality. Our technology evaluation services include system evaluation, selection, implementation, validation and document/meta-data migration services for Electronic Document Management (EDM) and Electronic Submission Publishing systems.
Additionally, we provide process and system tuning services to companies seeking increased efficiency from their existing EDM and Publishing systems.
Requirements Definition and System Evaluation
For EDM and Electronic Submission Publishing systems we evaluate:
- product features and functionality
- system cost and required hardware
- required customization
- validation requirements
- document migration from current systems to new/desired EDM systems
Implementation and Validation
Apyx services include technology implementation, development of validation strategy, creation of validation documentation and execution of validation test scripts.
Apyx has a defined and documented set of validation SOPs and Templates that provide a head start no matter which technology platform you chose. Our validation SOPs and templates are shell documents, complete with pre-completed content, encompassing all key validation areas that need to be addressed related to the implementation of EDM and/or e-sub software. We can use our processes and templates to manage your validation effort or we can provide them to your organization and train you on using them effectively.
Data Migration
Apyx’s data migration services include both manual data migration, when limited meta-data is available, to fully automated data migration. We help you transition from one document management system to another (e.g., when importing an acquired compound into your EDMS) as well as from completely paper-based to electronic publishing models, or from an existing electronic model to eCTD.
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News & Events
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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.