Datafarm is a leading Regulatory Submissions Solutions provider for life sciences. But even leaders use assistance as they strive to meet customer needs. For this purpose Datafarm partners with experienced industry leaders to ensure that we deliver a combination of technology and software services that customers require for achieving success.
Learn more about Our Partner Program please click here.
Strategic Partners:
CourtSquareGroup +1 413-746-0054 www.courtsquaregroup.com
Court Square Group is a professional consulting firm providing strategic information technology, project management and managed services. We also provide life science subject matter expertise in the areas of technology, quality and compliance and clinical.
K McCormick Consulting, LLC +1978-250-5044 www.kmccormickconsulting.com
K McCormick Consulting, LLC is a small consulting business comprised of results-driven, career-oriented professionals with 15+ years of combined consummate expertise in the pharmaceutical/biotechnology industry. This combination of expertise will answer your needs with knowledge and experience in Nonclinical/Clinical writing and Regulatory Affairs (including Regulatory Operations). KMC holds a superior track record of coordinating, compiling and publishing high quality and timely reports and submissions for FDA and global Regulatory Authority review, and well-organized proven processes for writing and review of protocols, study reports and submissions within deadline parameters. KMC provides services including (but not limited to) Medical Writing, Regulatory support, Regulatory Operations, Submission management and CTD training.
MasterControl +1 800-825-9117 www.mastercontrol.com
MasterControl Inc. is a global provider of GxP process and document management software solutions for life science companies. The MasterControl™ suite is easy to use, easy to deploy, easy to validate, and easy to maintain. It incorporates industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment across the enterprise. Hundreds of companies worldwide use MasterControl for easier compliance, faster validation, and better process management.
NextDocs +1 610-265-9474 www.nextdocs.com
NextDocs is the leading provider of fully FDA 21 CFR Part 11 compliant Microsoft SharePoint based document and quality management solutions for the life sciences companies. Our mission is to deliver cost effective, easy to use document management software which provides immediate productivity increases for companies operating in regulatory environments. NextDocs customers include Pharmaceutical companies, Bio-Techs, Medical Device companies and CROs.
Channel Partners:
Harlock, Italy
Epitome Technologies, India
Logica, Denmark +45 4483 8360 www.logica.com
Logica is a leading IT and business services company, employing 39,000 people across 36 countries. It provides business consulting, systems integration, and IT and business process outsourcing services. Logica works closely with its customers to release their potential – enabling change that increases their efficiency, accelerates growth and manages risk. It applies its deep industry knowledge, technical excellence and global delivery expertise to help its customers build leadership positions in their markets. Logica is a publicly traded company and is listed on both the London Stock Exchange and Euronext (Amsterdam) (LSE: LOG; Euronext: LOG).
Sirius Regulatory Consulting Ltd +44 1488 686449 www.siriusregulatory.com
Based in the UK, Sirius Regulatory Consulting Limited is a progressive Regulatory Affairs and Drug Development Consultancy supporting the global pharmaceutical industry to achieve product development and regulatory approval in Europe.
PEC (Pharmaceutical eConsulting A/S) +45 43 466 366 www.pec-cph.com
Pharmaceutical eConsulting Copenhagen A/S has extensive experience with compiling multiple submission types across regions, including MAA, CTA,
NDA, ANDA, IND, NDS matching the requirements from all health authorities. Submissions can be delivered in any format electronically
with XML (eCTD), electronically (volumised PDF), paper or hybrids according to client and relevant health authority requirements.
