Project - 1

Pharmaceutical discussion prospective -

R – Yes, sir

M – Are you able to hear me? ok Thank you – so without wasting any time – lets start with discussion here
ok, but before that am sure you are gone through the discussion guide which we shared with you right. So
before starting lesson 1 – I just want to – set up a background rule related to the call and also the
discussion guide that we have shared so only people who are discussing would unmute and talk, and rest
would go on mute.ok, so that would be the first thing, secondly, we have our major discussion related to
the service level , that the pre-service, preapproval and post approval and also the preapproval is been
separated into two levels of packages level 1 and level 2, I will not go through the details, cause believe
you already would have gone through it. Is that correct?

M – dheeraj, I just want one clarification -

R – yes please go ahead

M – can we introduce the people on this call.

R – Yes sure – extremely sorry about that – so we have janvi who is from recruitment team andwe have
our clients on the call, itself to , you know to listen and understand, if there is anything that is required, so
they will also ask you questions, just in case, if they have any questions. So I am the subject matter, I
would be modulating this conversation for an hour. From now Ok so yes –

M – and what would be the agenda of todays call , why am saying this cause I have already gone through
the guide, hence my expectations is pharmaceutical development –

R- ok

M – I don’t have experience in device development

R – ok so , do you have any questions – preeti ?

M – (preeti) – sir, we are looking for someone who is knowledgeable about, who can share their opinion
when it comes to both drug and product development but have been through the discussion guide ,
because we wont want to first confirm whether you think your aware of these services. – hello ?

R – ok , let me put across this was – sir ok - there are services which I have shared and which I have
discussed with you earlier also.so the services basically , the pre approval and the post approval for the
drug and device development and recycle management. So If You are aware of any one particular service
also – ok – based on your experience, ok you can share your knowledge based on that. Does that sound
good to you .

M – yeah –

R – before that,

M – yes please go ahead - hello ?

R – can you hear me sir - , sir can you hear me – can everyone hear me –
M – yes sir we can ?

M – dheerj –

M – deeraj - will it be ok for me to just interrupt in-between to just give the background,

R – yes please

M – thank you so much , thank you santosh sir, for giving your time and you know – getting on this call –
to just give a just give a background, about what we are looking at here –is from the prospective of
combination you know drug development since given, you know the COVID times vaccinations are going
to increases well as you might have seen that in territories like that India ,China – adulteration industries
are pretty open combination of product, approvals also increasing , so what we see is that the services
with in these landscape of combination drug development and for our questionnaire prospective – we are
looking at injectable combination products - from that prospective we see that services will likely grow
from that prospective , the questionnaire is also designed accordingly - I mean like the discussion guide
that has been shared with you. So what we like to know is that from that prospective of combination of
injectable products- I hope you will be knowledgeable and can definitely share some insights.

R – Yes – yes definitely.

M -Yes before that can you give me some idea?, this combination drug injectables approved anywhere in
the world or its first time you are going to file in for approval, or somewhere

R – no sir, we are actually looking at established pharma companies like yours who definitely have,
experience in registering drugs – with Asia as well as in EU and US. But since you know the landscape is
evolving and asia is next growing trajectory - we would like to know your prospective from the asia lens
as well.

Yeah – but the questionnaire is for established major companies like yours who , definitely have some
experience , who you know who definitely have experience you know in registering the drugs and have
good amount of market share- but from the combination injectable drug development prospective – we
would like to know you insights on the services - like to know how important these services are for you.
And which services are actually what would you prefer doing – how would you prefer doing inhouse or
outsource and what would you look in service provider, if you have to outsource the same for services. So
that is How the discussion going to be. From that prospective I guess you should be able to handle all this,
I mean am definitely sure. Yeah … thank you so much. Deeraj.