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ARCC services and products are a huge time and money saver that our organization depends on, year in and year out. We couldn’t live without it. We have been using ARCC to host a document management and eCTD publishing systems for many years.  All of our customers use RegDocs365 on SharePoint in the  cloud where they author, review and approve documents before handing them releasing them for publishing.  We use Adlib PDF Enterprise for MS Word to PDF conversion and OCR of PDF files.  We assemble submissions with  docuBridge or EXTEDO eCTD Manager.  We validate eCTD submissions with LORENZ eValidator and GlobalSubmit Validate+Load.  We upload submissions to FDA and Health Canada portals  from our production account.  ARCC qualified cloud enables us to quickly add new customer projects, assures the content for submission publishing is secure, enables customers to continue to edit documents while my team is assembling submissions and adding external hyperlinks, and provides high-speed performance because the cloud also includes all the applications my customers need to author/edit MS Word files, remediate PDF files, and review eCTD submissions.  Before ARCC, our customers were losing documents when their authors’ computers hard disks failed that were not backed up; were using different incompatible versions of MS Word; were manually converting MS Word to PDF files that were not compliant with agency specifications; and were uploading/downloading large files that sometimes took hours to complete. ARCC solved almost all of our worst headaches.

  • CEO of E-submissions and EDMS Integrator

I have been using Stabilityshire for consulting advice for the last year. They have consistently delivered results that are catered to my specific needs. Their reports are accurate, dependable, and easy to follow. Their customer service is excellent as requests, even general questions, are always followed up on directly and always in a timely manner.

  • Principal Scientist, Orphan Drug Development Company

Windshire consultants have a diverse skill set and exhibit deep knowledge of their subject matter. (They) are an extension of my own group. Interactions are frequent and discussions enlightening.

  • Senior Director, Technical Operations, Oral Dosage Pharmaceutical Company

As a CEO, I needed rapid and highly skilled assistance with complex CMC issues related to our NDA submission.  Windshire stepped in quickly with a no-nonsense approach and demonstrated the maturity and insight that one only sees with the most experienced industry veterans.  Windshire had access to a diverse and deep set of resources and fielded a team who delivered exactly what we needed.  Our submission was a success and Windshire helped the follow-on transition to our growing internal team.  I would gladly go back to Windshire for further CMC support as needs arise.  The Windshire team members developed a strong rapport with our full internal staff, not just me.  They were well-respected by all.

  • CEO of Multinational Pharmaceutical Company

Dr. Blackwell is a “make it happen” person! I have found him to be data driven, concise and quick to act. He is someone that can take a complex problem, develop a solution, implement it, and a drive it to completion. He emulates technical breadth and pace that will deliver high impact. James is the “person” that everyone searches for to solve problems. He is the only one to date where I have absolute confidence in providing an exceptional recommendation.

  • Vice President, Global Science-Based Health Product Manufacturer

James is extremely knowledgeable regarding many aspects of the pharmaceutical industry and was a huge help to me as a client from both a compliance and a technical perspective. James truly approaches projects with the client’s best interests in mind. He was responsive to our needs as a client, while also being highly collaborative with onsite personnel. He was very candid in situations where we might face some risk, but was also ready to help provide actionable solutions to problems we faced.

My whole team and I found James easy to work with, highly knowledgeable and happy to provide mentoring and coaching to site personnel. As a resource onsite, James consistently delivered results and was driven to help us meet milestones while maintaining a high level of compliance.

  • Director of QA Operations at industry-leading pharmaceutical company
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