| Good
knowledge of cGMP requirements, regulatory requirements,
DMF preparations and filing, systems development and implementation….
The Sr.Management of Shodhana led the earlier company
through 5 successful FDA inspections in various facilities
and in getting through ISO 9001 certification.
Patent evaluation, Implications and Patenting processes.
Polymorphism (Preparation of different polymorphs in
lab as well as in manufacturing scale, analysis by powder
XRD, DSC & IR and their interpretation).
Good knowledge about process development, scale up
and commercialization and adaptation of new processes
and technologies.
Has hands on experience in various chemical reactions.
To name a few are:
- Resolutions & racemization
- Reductions
- Oxidations
- Dieckmann Reaction
- Darzen's glycidic ester synthesis
- Alkylations
- Cyclizations
- Experienced in handling chemicals like phosphorous
oxychloride, thionyl chloride, Bromine etc
- Mannich Reaction, Grignard Reaction
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