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Submission: On August 07 via manual from IN — Scanned from DE
Submission: On August 07 via manual from IN — Scanned from DE
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Home Biopharma Publishing
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
* 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 SLP 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
* 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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