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Veeda CR has excellent
relations with health authorities in India
and the UK and can provide assistance in
regulatory submissions for bioequivalence
studies as well as compiling documents for
phase I-IV studies |
| |
Regulatory Submission process in
India |
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The documents required
for submission to the DCGI are equivalent
to those submitted for an IND. Veeda CR
is able to compile this documentation for
submission to the DCGI if required by the
Client. It then takes 8-10 weeks to get
permission from the DCGI to conduct phase
1 studies in India. However if it is a biotech
product it will also need clearance from
the Department of Biotechnology which would
required additional 4 weeks. |
| |
| Step by step process |
| Item |
Time |
| Receipt of documents |
Day 0 |
| Compilation of documents for IND |
10 days |
| Review by experts in DCGI as well
as ICMR |
8-10 weeks |
| Receipt of test license for import
of formulation |
concurrent |
| Approval of protocol by I.E.C for
phase 1 study |
2 weeks |
| Study initiation |
within 2 weeks of receipt
of samples & various approvals |
|
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| Conducting studies in the UK and
India |
| |
The process of submitting
documents to the respective health authorities
in the UK and India is the same. We would
advise documents are submitted to the DCGI
and MHRA simultaneously as the early approval
of the MHRA (4-5 weeks) expedites the review
of documents in India. The First in Man
study can then take place in the UK and
while this is occurring the approval from
the Indian health authorities can be obtained
and immediately following the FIM, multiple
dose escalation studies can be conducted
in India, this will prove to be cost effective.
It is important to inform both the health
authorities that there is an integrated
protocol which will be divided between the
two units. |
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| Download
Veeda CR regulatory presentation |
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