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IAGIM - Drug Development Association


IAGIM - Follow In Our International Policy Footsteps...
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Ready-To-Go CMC Dossiers

Technical Services
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A Division of IAGIM and LlG


GLOBAL 'PIGGY BACK' POLICY
Re: LOCUM INTERNATIONAL policy of Piggy Back File Dossier and Stability Data and the procedures to be implemented on a global basis.
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Current Policy
CURRENT POLICY STATEMENT
Our current policy being implemented with all global regulatory agency and MOH's is as follows"
STATUS of RAW DATA
Stability data is supplied as a SPECIAL PIGGY BACK Stability Agreement that stands alone separate from the purchase of the KNOW-HOW CMC Files.
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EXCLUSIONS
FULL RAW DATA IS NOT included in any Title 17 , Title 19 , Title 21 CMC 120+ Dossiers
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IAGIM KNOW-HOW POLICY

Know-how Files RESTRICTIONS
The time periods allowed for the use of LIG / IAGIM STABILITY DATA before members
STABILITY DATA @ 40 deg. C (concurrent 25 deg. C + 24 months) comes into force is given below.

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CURRENT PIGGY BACK USE PERIODS

CONTRACT PERIOD TO PIGGY BACK LIG DATABASE (Min & Max.)
3 months - $ quote as per product (~$ cost)
4 months - Plus (~$ cost) + 10% of Contract
5 months - Plus 20% (~$ cost) + 20% of Contract
6 months - Plus 50% (~$ cost) + 50% of Contract (Maximum period allowed to piggyback)

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VALIDITY SPECIFICATIONS

Stability Data + Raw data + Spectra + Assay + Full Assay Validation shall be placed on-line at secure locations to:
1. FDA OGD
2. EU Authorities
3. Local NON EU Authorities.
4. RoW Authorities (Asian, Pacific Rim, South America)

PRINT HARD COPIES
5. MOH + CLIENT ACCESS Relevant Web Access Keys will be provided to Client and relevant MOH/Agency
6. PRINT COPIES will be forwarded to MOH as per Specific Product DMF # VALIDITY + AVAILABILITY PERIOD.

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ACCESS PERIOD & EXPIRATION
After the 3, or 4, or 5 , or 6 month period has expired the file access will be then SEALED to all viewing and contracted parties and the in-house stability (40 deg. C data) GENERATED BY THE COMPANY (i.e. own CLIENT DATA) will become effective AND supercede LIG and IAGIM data for MOH / Agency review.
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TIME SENSITIVE DATA
ALL DATA IS TIME SENSITIVE
This is a TEMPORARY (non-permanent) system and procedure that allows immediate stability raw data access for a limited pre-agreed (and pre-paid) time period until own CLIENT accelerated stability data supersedes the existing LIG / IAGIM database on temporary loan to members.
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Non-Permanent Systems

By Members Agreement this "Piggy Back' agreement is a not a permanent system designed to circumvent the commitments the IAGIM MEMBER'S real time and accelerated stability data legal obligations to be performed in the members own laboratories with own drug finished product produced on own production equipment with own production staff and current SOPs.

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