Hetarthi Dave

FAQ About Hetarthi Dave

• What is Hetarthi Dave's address?

  Hetarthi Dave is located at
  Monroe, New Jersey, United States

• What is Hetarthi Dave's job title?

  Hetarthi Dave is a
  Regulatory Affairs: • Preparation of ANDA Labels according to RLD. • Side by side comparison of RLD and Generic product Labels. • Preparation of SPL using in-house tool. • Drug listing submission through ESG to FDA. • Facilitate Change Control processes to ensure required changes to component labeling have been completed and approved. • Coordinate with different department to compete the task on timely manner. • Review and approve all change control to bring cGMP accordance to FDA guidelines. • Preparation, review and compilation of regulatory document thorough eCTD. • CBE-0 and CBE-30 fillings. • Preparation, compilation, and coordination of electronic drug listings for FDA submissions as per FDA guidance for new product launches, product updates, and product de-listings. For Quality Assurance 1) Auditing of raw data, final concentration of the bio analytical data 2) LCMS/MS System Audit 3) In-Process Audit 4) Reviewing of the SOP and finalization 5) Internal audit For Learning and Development 1) Research Associate for Learning and development team, 2) given training of new employees as well as for existing employees related to SOP and Guidelines like GMP,GCP,GLP,ICMR. 3) Took mass session training of guidelines and SOPs. 4) Preparation of contents presentations of SOP and Guidelines. Tris Pharma

• What industry does Hetarthi Dave currently work in?

  Hetarthi Dave currently works in the
  Tris Pharma

• What is Hetarthi Dave's area of expertise?

  Hetarthi Dave specializes in
  Regulatory Affairs: • Preparation of ANDA Labels according to RLD. • Side by side comparison of RLD and Generic product Labels. • Preparation of SPL using in-house tool. • Drug listing submission through ESG to FDA. • Facilitate Change Control processes to ensure required changes to component labeling have been completed and approved. • Coordinate with different department to compete the task on timely manner. • Review and approve all change control to bring cGMP accordance to FDA guidelines. • Preparation, review and compilation of regulatory document thorough eCTD. • CBE-0 and CBE-30 fillings. • Preparation, compilation, and coordination of electronic drug listings for FDA submissions as per FDA guidance for new product launches, product updates, and product de-listings. For Quality Assurance 1) Auditing of raw data, final concentration of the bio analytical data 2) LCMS/MS System Audit 3) In-Process Audit 4) Reviewing of the SOP and finalization 5) Internal audit For Learning and Development 1) Research Associate for Learning and development team, 2) given training of new employees as well as for existing employees related to SOP and Guidelines like GMP,GCP,GLP,ICMR. 3) Took mass session training of guidelines and SOPs. 4) Preparation of contents presentations of SOP and Guidelines.

• Which languages does Hetarthi Dave speak? 

  Hetarthi Dave speaks the following languages:
  No languages available.

• Which industries has Hetarthi Dave previously worked in?   

  Hetarthi Dave has prior experience in the following industries:
  Otsuka Pharmaceutical Companies , Aurobindo Pharma Usa , Imedglobal

• What is Hetarthi Dave’s work experience?  

  Hetarthi Dave has the following professional experience:
  Tris Pharma , Otsuka Pharmaceutical Companies , Aurobindo Pharma Usa , Imedglobal .

• How can I find Hetarthi Dave on LinkedIn?  

  You can view Hetarthi Dave’s
  LinkedIn profile at LinkedIn URL.

• What are Hetarthi Dave’s work email addresses?  

  Hetarthi Dave’s work email addresses are
  [email protected] .

• What company does Hetarthi Dave work for?  

  Hetarthi Dave works at
  Tris Pharma