Manoj Shukla

FAQ About Manoj Shukla

• What is Manoj Shukla's address?

  Manoj Shukla is located at
  Mumbai, Maharashtra, India

• What is Manoj Shukla's job title?

  Manoj Shukla is a
  • Ealry phase and late phase clinical research expert Biopharmaceutical & bioanalytical & Clinical research management Expert • Experienced vice president with over 25 years of experience in Clinical research in CRO and Pharmaceutical. Excellent reputation for resolving problems, improving customer satisfaction, and driving overall operational improvements. Consistently saved costs while increasing profits. Possess unique set of knowledge and skills which includes in-depth understanding of business processes, business development and operational management at floor and strategic level. • Revenue goal settings, Business Plans, Strategic initiatives. • Handling Domestic sales as well as International Markets like the US, EU, Latin America and the ROW. • Skilled in designing human pharmacokinetic studies for different formulation and regulatory. • Adequately exposed for CRO, BA/BE, Clinical Research, GCP & GLP, PK & Stat., QMS, QA, Training, Business Development, HR, Admin and Finance. • Successfully, led many regulatory inspections: USFDA, WHO, EMEA ANVISA, NPRA, MHRA, DCGI, CAP, NABL, GLP (Thailand), GLP (OECD) & Clients (300+). • Good relation with Sponsor within India as well in North America. • 3000 plus methods expert in critical (low pg, stability issue, chiral, derivatization) and Large Molecules MAb and in-vitro. • Handled more than 100000 billable samples with Method and validation activities by using 50 LC-MS/MS/ 200staff. • Lab setup Lambda Ahmedabad, Lambada Canada, Panexcell. • Set up for typical formulation e.g., Injectables, Inhalers, Transdermal patches, Ointments & Creams, critical study for safety Fingolimod, Defotelite. • IT server infrastructure setup validation, all software validation in CRO as per 21CFR part11. Successfully faced USFDA(10),EMEA (05),WHO (02) ANVISA(5),MHRA(2) & DCGI(10) regulatory and more than 400 sponsor's inspections. Independently completed > 5000 BE studies and CT for regulatory submissions to USFDA/EU/ANVISA /UK MHRA ,WHO,ANSM Spain. Vimta Labs

• What industry does Manoj Shukla currently work in?

  Manoj Shukla currently works in the
  Vimta Labs

• What is Manoj Shukla's area of expertise?

  Manoj Shukla specializes in
  • Ealry phase and late phase clinical research expert Biopharmaceutical & bioanalytical & Clinical research management Expert • Experienced vice president with over 25 years of experience in Clinical research in CRO and Pharmaceutical. Excellent reputation for resolving problems, improving customer satisfaction, and driving overall operational improvements. Consistently saved costs while increasing profits. Possess unique set of knowledge and skills which includes in-depth understanding of business processes, business development and operational management at floor and strategic level. • Revenue goal settings, Business Plans, Strategic initiatives. • Handling Domestic sales as well as International Markets like the US, EU, Latin America and the ROW. • Skilled in designing human pharmacokinetic studies for different formulation and regulatory. • Adequately exposed for CRO, BA/BE, Clinical Research, GCP & GLP, PK & Stat., QMS, QA, Training, Business Development, HR, Admin and Finance. • Successfully, led many regulatory inspections: USFDA, WHO, EMEA ANVISA, NPRA, MHRA, DCGI, CAP, NABL, GLP (Thailand), GLP (OECD) & Clients (300+). • Good relation with Sponsor within India as well in North America. • 3000 plus methods expert in critical (low pg, stability issue, chiral, derivatization) and Large Molecules MAb and in-vitro. • Handled more than 100000 billable samples with Method and validation activities by using 50 LC-MS/MS/ 200staff. • Lab setup Lambda Ahmedabad, Lambada Canada, Panexcell. • Set up for typical formulation e.g., Injectables, Inhalers, Transdermal patches, Ointments & Creams, critical study for safety Fingolimod, Defotelite. • IT server infrastructure setup validation, all software validation in CRO as per 21CFR part11. Successfully faced USFDA(10),EMEA (05),WHO (02) ANVISA(5),MHRA(2) & DCGI(10) regulatory and more than 400 sponsor's inspections. Independently completed > 5000 BE studies and CT for regulatory submissions to USFDA/EU/ANVISA /UK MHRA ,WHO,ANSM Spain.

• Which languages does Manoj Shukla speak? 

  Manoj Shukla speaks the following languages:
  No languages available.

• Which industries has Manoj Shukla previously worked in?   

  Manoj Shukla has prior experience in the following industries:
  Veeda Clinical Research , Mediclin Clinical Research , Lambda Therapeutic Research , Lambda Therapeutic Research , Lambda Therapeutic Research , Suven Life Sciences , Zydus Cadila

• What is Manoj Shukla’s work experience?  

  Manoj Shukla has the following professional experience:
  Vimta Labs , Veeda Clinical Research , Mediclin Clinical Research , Lambda Therapeutic Research , Lambda Therapeutic Research , Lambda Therapeutic Research , Suven Life Sciences , Zydus Cadila .

• How can I find Manoj Shukla on LinkedIn?  

  You can view Manoj Shukla’s
  LinkedIn profile at LinkedIn URL.

• What are Manoj Shukla’s work email addresses?  

  Manoj Shukla’s work email addresses are
  [email protected] .

• What company does Manoj Shukla work for?  

  Manoj Shukla works at
  Vimta Labs