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Global Regulatory Publishing Services

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

  • Bullet 20+ years experience and 500+ customers served in Regulatory
  • Bullet 24×7 Operations with submissions to FDA, EMA and other health authorities around the Globe
  • Bullet Over 2,000+ regulatory submissions done every year
  • Bullet Leverage our publishing and eCTD tools or we can work in your environment
  • Bullet 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

  • 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

  • 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

    • BulletProven Best Practices developed by MakroCare with years of experience
    • BulletShort Timelines delivered by efficient teamwork
    • BulletGlobal teams and automation help reduce overall costs
    • BulletStrong relationships with regulators enable rapid troubleshooting
    • BulletCustom 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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    The First Step

    Let's talk about how MakroCare can help you