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

POA issuance and shipping

MAH

week 1

1

  0.4

Invoice is sent to MAH and paid

Executor

week 1

1

  0.5

Legal Document processing

Executor

week 2

1

  0.6

Legal Document Translations, Notary, and Apostilles 

3rd party

week 2

2

  0.7

SOW is approved by MAH

Executor

week 4

1

SOW

I

Submission

  I.1

Providing documents and registration file

MAH

week 5

1

  I.2

Ensure alignment with local regulatory guidelines

Executor

week 6

2

  I.3

Translations and document processing

3rd party

week 8

2

  I.4

Filling out the application form

Executor

week 10

1

  I.5

Approval of the application form

MAH

week 10

1

  I.6

Submission of the New Drug Application and Reg. File

Executor

week 11

1

Application

  I.7

    NRA payment

MAH

week 11

1

Confirmation

II

NRA Evaluation

  II.1

Application review

NRA

week 12

2

  II.2

Registration file review

NRA

week 13

4

  II.3

Determining of Specific lab testing requirements

NRA

week 17

1

  II.4

State-approved lab contracting

Executor

week 18

2

  II.5

Samples and Ref. Standards permit obtaining 

Executor

week 20

1

  II.6

Samples and Ref. Standards shipping

MAH

week 21

2

  II.7

Samples and Ref. Standards custom clearance

Executor

week 23

1

  II.8

Optional clinical evaluation (in some countries)

Executor

week 24

8

  II.9

Verification of medication guidelines and drug labeling

NRA

week 32

2

  II.10

Verification of DHCP Letter and Communication Plan

NRA

week 32

2

  II.11

Approval or Query

NRA

week 33

1

Approval or Q&A

III

Q&A

  III.1

Analysis and addressing Qs to MAH

Executor

Mnth 8

1

  III.2

Answering with relevant documents

MAH

Mnth 8

1

  III.3

Official Response Evaluation

NRA

Mnth 8

1

  III.4

Approval or Query

NRA

Mnth 8

1

Approval or Q&A

IV

Approval

  IV.1

Market Authorization Approval

NRA

Mnth 9

1

  IV.2

Reporting to MAH, compliance check

Executor

Mnth 10

1

Approval

  IV.3

Listing in the state register

Executor

Mnth 10

1

Listing

F

Final Phase In-house Post-Authorization Activity

  F.1

Service Acceptance Certificate signing

MAH

Mnth 10

1

  F.2

Final Invoice

Executor

Mnth 10

1

  F.3

Final Payment

MAH

Mnth 10

1

  F.4

Contract Termination

Executor

Mnth 10

1

  F.5

Archiving and limiting access

Executor

Mnth 10

1

Archiving