Regulatory publishing is manual, time-consuming, repetitive and most of the time its “urgent” coupled with last minute document changes. Large companies add a little more complexity to this with different IT tools, internal standards, and other steps.

MakroCare has been supporting Regulatory Operations for 20+ years and the experience gained in tactical projects down for startup/small firms to strategic/FSP work done for large companies will be utilized for your projects.

Proven Track Record

  • 20+ years experience and 500+ customers served in Regulatory
  • 24×7 Operations with submissions to FDA, EMA and other health authorities around the Globe
  • Over 2,000+ regulatory submissions done every year
  • Leverage our publishing and eCTD tools or we can work in your environment
  • Well-defined processes to continually improve consistency, efficiency, quality control and risk mitigation

Our services include Document publishing (DLP), Reports publishing (RP) and Submission publishing (SLP) while handling all project management / communications with our cloud based tools.

DLP/RP

  • Word/PDF formatting with HA and company Rule books
  • Bookmarks or Hyperlinking
  • QC done with Tools
  • Report level includes Clinical, Non-Clin, CMC and Labeling documents

SLP

  • eCTD
    • IND
    • NDA or MAA
    • ANDA
    • DMF
    • Amendments or Supplements
  • NeeS and other countries publishing

At MakroCare, we pride ourselves on our attention to detail and focus on turn-around-time. We follow a documented quality control process to ensure that each submission is error-free and meets all the necessary requirements. Our team of experts has the expertise and experience to handle all aspects of the publishing process, from DLP to validation and submission tracking.

Benefits with MakroCare

  • Proven Best Practices developed by MakroCare with years of experience
  • Short Timelines delivered by efficient teamwork
  • Global teams and automation help reduce overall costs
  • Strong relationships with regulators enable rapid troubleshooting
  • Custom made processes to suit your needs and organization

 

Please Contact us today to learn more about our regulatory operations and publishing services and how we can help you meet your regulatory requirements that are compliant.

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