Dear Sir/Madam,
Please provide rate and lead time for below KSMs ( Key Starting Material ). 
These all are KSMs so we need all following documents for the same.
All documents must be on Manufacturer’s letter head with stamp & sign only.

List of Regulatory documents:

Sr.No. Description
1 DUNS / FEI number
2 Filled vendor questionnaire (Pls check attachment)
3 Specification
4 3 batch COA & Method of Analysis (MOA)
5 TSE/BSE declaration
6 GMP declaration and certificate
7 Declaration on change intimation
8 Complete route of synthesis (ROS)
9 Process Flow Diagram ( PFD ) & Brief Manufacturing Process
10 List of RMs (reagents, solvents, catalysts etc)
11 BMR (Batch manufacturing Record) :
There are three options: I) Please provide BMR to Apicore, we must need it or II) Please directly submit it to USFDA and provide submission letter or III) Provide GMP Certificate
12 Declaration on willingness to be audited
13 Declaration on 1 year of advance product manufacturing close down intimation
14 MSDS
15 Contract Agreement (Will share later on)
16 Debartment Certificate (Pls check attachment)
17 Patent Non-infringement statement
18 EHS Check list (Pls check attachment)