Gaurang Patel

FAQ About Gaurang Patel

• What is Gaurang Patel's address?

  Gaurang Patel is located at
  Bridgewater, New Jersey, United States

• What is Gaurang Patel's job title?

  Gaurang Patel is a
  • A Self-motivated, enthusiastic, experienced professional skilled in pharmaceutical preformulation, formulation and process development, scale-up, validation and global regulatory submissions of solid oral dosage forms. • Proficient in GMP, DEA regulations and global CMC regulatory requirements for development and approval of drug products. Leveraging extensive hands on training working within cGMP manufacturing facilities & GLP laboratories and familiarity with FDA/ICH/SUPAC regulatory compliance. • Hands on experience with equipment and processes commonly used for solid oral formulation development • Experience working in a fast-paced cross-functional environment. • A proven track record in developing and scaling up formulations for oral administration from pre-clinical to clinical stages. • Identify root cause for effective trouble shooting to analyze formulation/process variables affecting drug product CQA and QTPPs based on the CPPs. • Author and review relevant drug product sections in the CMC sections for FDA regulatory submissions, internal and vendor reports. • Valuable team member, organized, detailed oriented and dedicated person with excellent leadership, interpersonal communication, presentation and organizational skills • Experience in writing research publications. Expertise: • Development of complex generic solid oral dosage forms utilizing different manufacturing technologies such as multiparticulate bead coating, pan coating, nano-milling, extrusion, spheronization, hot-melt extrusion, granulation, compression, rotor dry powder layering, hot melt coating, softgel manufacturing, roller compaction, high-pressure homogenization etc. • Bioavailability enhancement using nanotechnology and amorphous solid dispersion • Process optimization using DOE and QBD principles • Bio-risk assessment and IVIVR • Pre-formulation, quantitative analysis, physicochemical characterization of materials, in-vitro evaluation of pharmaceutical formulations • Excellent writing skills and preparation of high quality ANDA submission documents (Modules 2.3.P and Module 3.2.P) and deficiency responses • Knowledge of global CMC regulatory requirements for development and approval of drug products. Research interests: • Bioavailability enhancement using nanoparticles and amorphous solid dispersions • Abuse deterrent technologies • ODT platforms • Lipid and polymer based technologies • Implants • 3D printing formulation Amneal Pharmaceuticals

• What industry does Gaurang Patel currently work in?

  Gaurang Patel currently works in the
  Amneal Pharmaceuticals

• What is Gaurang Patel's area of expertise?

  Gaurang Patel specializes in
  • A Self-motivated, enthusiastic, experienced professional skilled in pharmaceutical preformulation, formulation and process development, scale-up, validation and global regulatory submissions of solid oral dosage forms. • Proficient in GMP, DEA regulations and global CMC regulatory requirements for development and approval of drug products. Leveraging extensive hands on training working within cGMP manufacturing facilities & GLP laboratories and familiarity with FDA/ICH/SUPAC regulatory compliance. • Hands on experience with equipment and processes commonly used for solid oral formulation development • Experience working in a fast-paced cross-functional environment. • A proven track record in developing and scaling up formulations for oral administration from pre-clinical to clinical stages. • Identify root cause for effective trouble shooting to analyze formulation/process variables affecting drug product CQA and QTPPs based on the CPPs. • Author and review relevant drug product sections in the CMC sections for FDA regulatory submissions, internal and vendor reports. • Valuable team member, organized, detailed oriented and dedicated person with excellent leadership, interpersonal communication, presentation and organizational skills • Experience in writing research publications. Expertise: • Development of complex generic solid oral dosage forms utilizing different manufacturing technologies such as multiparticulate bead coating, pan coating, nano-milling, extrusion, spheronization, hot-melt extrusion, granulation, compression, rotor dry powder layering, hot melt coating, softgel manufacturing, roller compaction, high-pressure homogenization etc. • Bioavailability enhancement using nanotechnology and amorphous solid dispersion • Process optimization using DOE and QBD principles • Bio-risk assessment and IVIVR • Pre-formulation, quantitative analysis, physicochemical characterization of materials, in-vitro evaluation of pharmaceutical formulations • Excellent writing skills and preparation of high quality ANDA submission documents (Modules 2.3.P and Module 3.2.P) and deficiency responses • Knowledge of global CMC regulatory requirements for development and approval of drug products. Research interests: • Bioavailability enhancement using nanoparticles and amorphous solid dispersions • Abuse deterrent technologies • ODT platforms • Lipid and polymer based technologies • Implants • 3D printing formulation

• Which languages does Gaurang Patel speak? 

  Gaurang Patel speaks the following languages:
  No languages available.

• Which industries has Gaurang Patel previously worked in?   

  Gaurang Patel has prior experience in the following industries:
  Kashiv Specialty Pharmaceuticals , Kashiv Pharma , Kashiv Pharma , Kashiv Pharma

• What is Gaurang Patel’s work experience?  

  Gaurang Patel has the following professional experience:
  Amneal Pharmaceuticals , Kashiv Specialty Pharmaceuticals , Kashiv Pharma , Kashiv Pharma , Kashiv Pharma .

• How can I find Gaurang Patel on LinkedIn?  

  You can view Gaurang Patel’s
  LinkedIn profile at LinkedIn URL.

• What are Gaurang Patel’s work email addresses?  

  Gaurang Patel’s work email addresses are
  [email protected] .

• What company does Gaurang Patel work for?  

  Gaurang Patel works at
  Amneal Pharmaceuticals