Ganesh Phad Email & Phone Number

Mumbai, Mh, In

Mumbai, Maharashtra, India

Compilation, review and submission of ANDA, MAA, ANDS, Dossier, deficiency responses and post approval supplements or variations for US, EU, Canada and ROW markets for oral solids, injectables and peptides

Mumbai, Maharashtra, India

Responsible for compilation, review and submission of Deficiency Responses, ANDA, FAR, ANDA/Dossier/ANDS Review and Gap Analysis for US, Europe & Canada Markets

Mumbai Area, India

Responsible for compilation and submission of Deficiency Responses, ANDA Review and Gap Analysis for US Market

Mumbai Area, India

Compilation and submission of ANDAs, NDAs to USFDA in eCTD format.  Provide strategic input into the development of submissions and timelines for assigned products/projects, seeking guidance where appropriate.  Review and compilation of Drug Master File as part of ANDA.  Compilation and submission of Amendments (Information Request, Labeling, Patent and Deficiency Responses) to ANDAs and Supplements (PAS, CBE-30 and CBE-0) to USFDA.  Review of technical documents received from other departments prior to submission with Health Authorities.  Co-ordinate with related departments for the documents required for compilation of ANDA/Amendment. 

Pune, Maharashtra, India

Responsible for addressing the deficiencies conveyed by USFDA, EDQM and various other Regulatory agencies.

Hyderabad, Andhra Pradesh, India

Responsible to prepare, assemble, review and/or evaluate and to submit DMF to US, EU, Japan and ROW countries in eCTD, NeeS and CTD format.  Responsible to submit amendments, annual reports, variation and additional documentation, as needed in an efficient and timely manner.  Maintaining product life cycle, Familiar with ICH, FDA and GMP guidelines and various Regulatory Authorities guidelines of different countries.

Zahirabad, Andhra Pradesh, India

Responsible to prepare, assemble, review, and/or evaluate and submission of DMF to US as well as EU in hard copy and NeeS format.  Responsible to submit amendments, annual reports, variation and additional documentation, as needed in an efficient and timely manner.  Maintaining product life cycle, Familiar with ICH, FDA and GMP guidelines and various Regulatory Authorities of different countries.  Knowledge about quality system.

Sangola, Maharashtra, India

Teaching of subjects, Pharmaceutical Chemistry and Pharmaceutical Analysis to B. Pharm 3rd year students

Master Of Pharmacy [Pharmaceutical Chemistry], Pharmacy, First Class With Distinction

Bachelor Of Pharmacy (B.Pharm.), Pharmacy, First Class