Pyxa Solutions is comprised of a dynamic team of management consultants and R&D subject matter experts specializing in cross-functional R&D delivery stemming from activities led by Regulatory Affairs. Pyxa was founded in 2012 to provide our clients a refreshing consulting experience, through engagement with experienced industry leaders and consultants by delivery of high-quality deliverables and unique services. Pyxa is managed by a team of three seasoned partners with prior blended expertise in industry and management consulting.

1. DirectusPro, a Unique Label
Management, Tracking and
Reporting Solution, is the
only comprehensive global
labeling system that
addresses the market gap
in providing a system that
can effectively and
efficiently enable a Global
End-to-End Labeling
Process.
Ensuring efficient information flow
from source label (CCDS or other)
to local labels and across all local
labels.
Ensuring consistent scientific,
medical and administrative
information across all labels
Globally.
Ensuring traceability of history
changes globally at the content level
(not only at the document level)
Drive Operational Excellence
Stay Compliant
Streamline Tracking and Reporting
AdministrationTrackingRPI ManagementCCDS ManagementDocuments Library
The ability to track and manage
simultaneous label updates, ensuring
compliance with the latest approved
version
Management of Simultaneous
Labels in Review
The ability to track and monitor
Label compliance from Source
Label to Local Labels.
Track and monitor
label compliance
The ability to compare Labels and
manage content from version to version
or label to label.
Label Comparison
and Alignment
DirectucPro Features
v. 0.1
v. 2.1
v. 2.2
v. 2.3
v. 2.4
v. 2.0.1.0
v. 2.0.1.1
v. 2.0.1.2
v. 2.0.2.0
v. 2.0.2.1
v. 2.0.3.0
v. 2.0.3.1
v. 2.0.2.2
v. 2.5
v. 4.0
v. 3.0
v. 2.0
Generic name ® 250/1250
01 March, 2018
TRADE NAME OF THE MEDICAL PRODUCT1.
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te tantas lobortis honestatis, ius ad commodo fuisset Dicta dicam
maiestatis ut quo. Sed mazim officiis conclusionemque in. Pro te tantas
lobortis honestatis, ius ad commodo fuisset.
QUALITATIVE AND QUANTITATIVE COMPOSITION2.
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nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat
volutpat. Ut wisi enim ad minim consectetuer adipiscing veniam, quis
nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip
PHARMACEUTICAL FORM3.
Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam
nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat
volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation
ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat.
- Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse
molestie consequat, vel illum dolore eu feugiat
- Nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit
Lorem ipsum dolor sit amet, cons ectetuer adipiscing elit, sed diam
nonumLorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam
nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat
volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation
ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat.
Company Core Data Sheet (CCDS)
Generic name ® 250/1250
12 March, 2018
TRADE NAME OF THE MEDICAL PRODUCT1.
Dicta dicam maiestatis ut quo. Sed maiestatis in. Pro te tantas lobortis
honestatis, ius ad commodo fuisset Dicta dicam maiestatis ut quo. Sed
mazim officiis conclusionemque in. Pro te tantas lobortis honestatis, ius ad
commodo fuisset.
QUALITATIVE AND QUANTITATIVE COMPOSITION2.
Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam
nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat
volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation
ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat.
PHARMACEUTICAL FORM3.
Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam
nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat
volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation
ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat.
- Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse
molestie consequat, vel illum dolore eu feugiat
- Nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit
Lorem ipsum dolor sit amet, cons ectetuer adipiscing elit, sed diam
nonumLorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam
nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat
volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation
ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat.
Company Core Data Sheet (CCDS)
API_CCDS_Version##_Clean... API_CCDS_Version##_Clean...
Monthly
Deadlines
breakdown
Pending
Updated Past Due Date
Updated by Due Date
Incomplete Past Due Date 18TOTAL NUMBER OF LABELS
Compliance by countries
To date Current quarter Visit detailed statsTo date Current quarter Visit detailed stats
JAPAN 10%2
%
COMPLETED VS PLANNED,
USA 5 80%
FRANCE 60%2
GERMANY 30%2
CANADA 20%2
UK 30%1
SWEDEN 30%1
NETHERLANDS 30%1
BELGIUM 30%1
AUSTRALIA 30%1
TotalnumberofCCDS
Incomplete Past Due DateCompliance dynamics
0
20
40
60
80
100
Breakdown
PendingUpdated by Due Date Updated Past Due Date
AprMarFebJan May Jun Jul Sep Oct Nov Dec Jan
Cumulative
FEATURED FUNCTIONALITYFEATURED FUNCTIONALITYFEATURED FUNCTIONALITY
For more information contact us: Info@pyxasolutions.com© 2018 Pyxa Systems, LLC. All rights reserved.
Document Management Workflows
(e.g. Authoring , Review and Approval)
Notifications / Tasks
Roles based permissions
Document status tracking
Label comparison
Collaborative Authoring
Document version control
Content version control
CCDS Repository and Management
RPI Repository and Management
HA Correspondences Management
CCDS and RPI Dissemination
Inbox / Tasks functionality
Outlook integration
Label Tracking (Document and Content)
Management and tracking of label
dissemination
Automated reporting and compliance
tracking