PHASE

TASK

TASK

START

DURATION

Fee

KPI

NUMBER

TITLE

OWNER

W/M/Q/Y

in weeks

3rd Party 

Service 

State

0

In-house Pre-Submission Activity

  0.1

NDA signing or validation

Executor

week 1

1

  0.2

Contract Closing

MAH

week 1

1

  0.3

SOW is approved by MAH

MAH

week 1

1

SOW

  0.4

POA issuance and shipping

MAH

week 2

1

  0.5

Invoice is sent to MAH and paid

MAH

week 3

1

POP

I

Submission

  I.1

Information assembling, forwarding to Executor

MAH

week 4

1

  I.2

Application form and Registration form development

Executor

week 5

2

Application

  I.3

Application form and Registration form approval

MAH

week 7

1

  I.4

NRA payment

MAH

week 7

1

  I.5

Application submission to NRA

Executor

week 8

1

Submission

II

Official Evaluation

  II.1

Official Dossier Evaluation

NRA

week 9

4

  II.2

Approval (Skip Ph.III) or Query (GoTo Ph.III)

NRA

week 13

1

Approval or Q&A

III

Q&A

  III.1

Analysis and addressing Qs to MAH

Executor

week 13

1

  III.2

Answering with relevant documents

MAH

week 14

1

  III.3

Official Response Evaluation

NRA

week 15

8

  III.4

Approval (GoTo Ph.IV) or Query (Rpt. Ph.III)

NRA

week 23

1

Approval or Q&A

IV

Approval

  IV.1

NRA Conclusion draft verification

NRA

week 24

1

  IV.2

NRA Conclusion publication

NRA

week 25

1

  IV.3

State Listing update

NRA

week 26

1

  IV.4

Reporting  to MAH

Executor

week 26

1

Report

F

Final Phase In-house Post-Authorization Activity

  F.1

Service Acceptance Certificate signing

MAH

week 27

1

  F.2

Final Invoice

Executor

week 27

1

  F.3

Final Payment

MAH

week 28

1

  F.4

Contract Termination

Executor

week 28

1

  F.5

Archiving and limiting access

Executor

week 29

1

Archiving