Mahesh Soni

FAQ About Mahesh Soni

• What is Mahesh Soni's address?

  Mahesh Soni is located at
  Ahmedabad, Ahmedabad, India

• What is Mahesh Soni's job title?

  Mahesh Soni is a
  • Experienced in preparing the project planning and tracking; creating key milestone and performance indicators • Development of multiple Infusion bag projects for cyto/ Noncyto/Narcotic and psychotropic substance for US and EU market • QbD based ANDA and 505(B2) injection development for US and EU market • Experienced in the drafting of QbD based PDR and Technology transfer document like MF, Risk assessment • Experienced in designing the study, reviewing protocol and report for extractable and leachable study • Drafted science and risk based justification to respond the regulatory query of different regulated market • Experienced in drafting science and risk based justification for query-response to US and EU regulatory agencies. • Trained and experienced in handling statistical tools viz factorial designs and Measurement system analysis (MSA) for screening and optimization of product/process. • Experienced in shelf life evaluation, trend analysis, and process capability evaluation • Knowledge of Briefing package review, Dose banding/rounding for cyto product and PK simulation for 505B2 filling. • Design and development of Ion-exchange based drug complexation for taste masking of Antibiotics. • Worked on Design, development and scale up of polymer lipid hybrid nanoparticles and lipid nanoparticles as a part of doctoral thesis • Toxicity profiling (Acute/ Subacute/ Genotoxicity) and Biodistribution study of nanoparticles in rodent model Intas Pharmaceuticals

• What industry does Mahesh Soni currently work in?

  Mahesh Soni currently works in the
  Intas Pharmaceuticals

• What is Mahesh Soni's area of expertise?

  Mahesh Soni specializes in
  • Experienced in preparing the project planning and tracking; creating key milestone and performance indicators • Development of multiple Infusion bag projects for cyto/ Noncyto/Narcotic and psychotropic substance for US and EU market • QbD based ANDA and 505(B2) injection development for US and EU market • Experienced in the drafting of QbD based PDR and Technology transfer document like MF, Risk assessment • Experienced in designing the study, reviewing protocol and report for extractable and leachable study • Drafted science and risk based justification to respond the regulatory query of different regulated market • Experienced in drafting science and risk based justification for query-response to US and EU regulatory agencies. • Trained and experienced in handling statistical tools viz factorial designs and Measurement system analysis (MSA) for screening and optimization of product/process. • Experienced in shelf life evaluation, trend analysis, and process capability evaluation • Knowledge of Briefing package review, Dose banding/rounding for cyto product and PK simulation for 505B2 filling. • Design and development of Ion-exchange based drug complexation for taste masking of Antibiotics. • Worked on Design, development and scale up of polymer lipid hybrid nanoparticles and lipid nanoparticles as a part of doctoral thesis • Toxicity profiling (Acute/ Subacute/ Genotoxicity) and Biodistribution study of nanoparticles in rodent model

• Which languages does Mahesh Soni speak? 

  Mahesh Soni speaks the following languages:
  No languages available.

• Which industries has Mahesh Soni previously worked in?   

  Mahesh Soni has prior experience in the following industries:
  Sun Pharma , Macleods Pharmaceuticals

• What is Mahesh Soni’s work experience?  

  Mahesh Soni has the following professional experience:
  Intas Pharmaceuticals , Sun Pharma , Sun Pharma , Macleods Pharmaceuticals .

• How can I find Mahesh Soni on LinkedIn?  

  You can view Mahesh Soni’s
  LinkedIn profile at LinkedIn URL.

• What are Mahesh Soni’s work email addresses?  

  Mahesh Soni’s work email addresses are
  [email protected] .

• What company does Mahesh Soni work for?  

  Mahesh Soni works at
  Intas Pharmaceuticals