[Company name]
Registration No.: [Registration number]
Address: [Legal address]
[Location], [date, month], 2014.
No.__________________
Technical offer
1.
2.
3.
4.
5.
6.
7.
1.
Joint Stock Company „Grindeks”
Beneficiary of funding:
Address of Beneficiary of Krustpils iela 53, Riga, LV-1057 Latvia
funding:
Development of new patentable lyophilized final dosage forms
Procurement object:
of the compound GX-EG.
Krustpils iela 53, Riga, LV-1057 Latvia
Place of Contract
execution:
30.12.2014.
Terms for execution of
Contract:
[Company name], Registration No.: [Registration number],
Information about
[Legal address]
potential contractor:
[Short description of the capabilities and type of work
performed by the company]
Technical Specification of Procurement Object:
Development of new patentable lyophilized final dosage forms of the compound GX-EG.
Requirements
Offer
Scope of the
Development of formulation and
work:
technology, as well as the preparation
of the following lyophilized final
dosage forms of the compound GXEG:
1) Dosages of 100 mg in 5 mL vials,
3 batches of 5,000 vials each (not
prepared under the conditions of
current Good Manufacturing
Practice (cGMP)).
2) Dosages of 10 mg in 5 mL vials, 3
batches of 5,000 vials each (not
prepared under the conditions of
cGMP).
The activities to be performed:
1) Project preparation for the new
lyophilized formulations,
2) Development of final dosage form
compositions,
3) Pre-stability testing,
4) Technology development for the
1
5)
6)
2.
The methods
used:
1)
2)
3)
3.
Quality
requirements
for the final
product:
preparation of the lyophilized
final dosage forms,
Preparation of batches,
Writing
of
final
report
(Development part of the Module
3) according to the requirements
set
by
the
International
Conference on Harmonisation of
Technical
Requirements
for
Registration of Pharmaceuticals
for Human Use (ICH).
The compound GX-EG* (3.0 kg)
will be supplied by the
Beneficiary of funding. All other
starting materials used must be
commercially available.
Only pharmaceutically acceptable
materials according to the ICH (or
equivalent) guidelines must be
used in contact with the product.
The starting materials, process
intermediates, and the prepared
final product must be analysed
with the methods of analysis
suplied by the Beneficiary of
funding.
Specification
Requirements
Description
Identity
White or
almost white
powder
Corresponds
Related
impurities:
- any
individual2
- sum
Not more than
0.1%
Not more than
0.5%
Sterility
Bacterial
endotoxins
GX-EG assay
Sterile
Not more than
3.5 IU / mg
95.0%-105.0%
Methods of
Analysis
Visually
In-house method:
capillary
electrophoresis
(CE)
In-house method:
High performance
liquid
chromatography
with a mass
spectral detector
(HPLC-MS)
Ph.Eur.1, 2.6.1
Ph.Eur.1, 2.6.14
In-house method
(titration)
1
European Pharmacopoeia (Ph.Eur.) current edition.
2
Related impurities:
- N-Diethyl-N,N-dimethylammonium bromide (Impurity
A)
- 4-(4-Ethoxy-4-oxobutoxy)-N-ethyl-N,N-dimethyl-4oxobutane-1-ammonium bromide (Impurity B)
- N-Ethyl-4-methoxy-N,N-dimethyl-4-oxobutan-1ammonium bromide (Impurity C)
- N-Ethyl-4-ethoxy-N,N-dimethyl-4-oxobutan-1ammonium bromide (GX-EG2 IP.1)
2
- N-Ethyl-4-isopropoxy-N,N-dimethyl-4-oxobutan-1ammonium bromide (Impurity D)
8.
1.
2.
3.
Additional requirements (preferable):
Requirements
Offer
Track record:
1) The applicant must have
personnel with higher education and
experience in the field of lyophilized
formulation
development
and
preparation, as well as necessary
equipment
for
lyophilized
formulation
development
and
preparation.
2) The applicant must have finished
at least 3 (three) contract or selffinanced lyophilized formulation
development and/or manufacturing
projects within the last 3 (three)
calendar years.
The applicant must provide a
statement and/or other documental
evidence of the required track
record.
Conditions of
The project documentation, reports
delivery:
and the prepared product must be
delivered to the Beneficiary of
funding according to the Project
deadlines.
Project
1) Project preparation for the new
deadlines:
lyophilized formulations: April 30,
2014.
2) Development of the new
lyophilized
formulations
(intermediate report): June 30, 2014.
3) Pre-stability testing. Pre-stability
plan must be submitted to the
Beneficiary of funding at the
beginning of pre-stability testing. A
report must be submitted after each
testing point. Pre-stability testing
must start before June 30, 2014 and
must continue for 6 months.
4) Technology development for the
preparation of the lyophilized form
(intermediate report about the results
of technology development): July
30, 2014.
5) Delivery of the prepared
3
4.
5.
6.
7.
8.
Scope of the
offer:
Equivalent
offers:
Payment
schedule:
Price:
Requirements
for the offer
preparation:
lyophilized form according to the
specification: November 30, 2014.
6) Preparation and delivery of the
final report to the Beneficiary of
funding: December 30, 2014.
The offer shall cover the entire
scope of the project.
If the technical specification can be
fulfilled by equivalent means,
unforseen by the Beneficiary of
funding, then a corresponding offer
may be submitted.
20% advance payment.
Must be indicated in EUR without
VAT. The cost of delivery must be
included in the price. The price must
be indicated for two positions
separately:
1. Project preparation for the new
lyophilized
formulations
and
development of the new lyophilized
formulations,
2. Pre-stability testing, technology
development for the preparation of
the lyophilized forms, preparation of
the lyophilized forms according to
the specification, and preparation of
the final report.
- 2 (two) signed original tender
offers typed either in the Latvian
or English language must be
submitted;
- The applicant shall indicate the
date and the place of preparation of
the offer, registration number of
the offer, as well as the signature
and deciphering of signature of
applicant’s representative.
- The applicant shall print the first
page of the offer on a company
letterhead (if applicable).
[Name of Company] [Position]
______________________[Name, Surname]
4