rajkumar gupta

director

About

Pharmaceutical Consultant for US DMF, EDMF ,Dossier, CEP, CTD,eCTD, NEES,cGMP ,DCGI Import Authorizations, Label Review

Country

india

City

pune

Industry

pharmaceuticals

Skill

clinical trials, medical writing, distribution, cro, chemistry, ectd, gmp, dermatology, sales, market development, iso 13485, dmf, biotechnology, regulatory affairs, change control, software documentation, validation, cleaning validation, dissolution, regulatory requirements, quality by design, pharmacovigilance, generic programming, drug discovery, quality system, analytical chemistry, lifesciences, operations management, v&v, marketing, pharmaceutics, quality auditing, drug development, clinical development, gcp, manufacturing, mhra, storage, regulatory submissions, ctd, anda, vaccines, formulation, cmc, product development, quality control, pharmaceutical industry, technology transfer, toxicology, capa, fda, r&d, sop, biopharmaceuticals

Experience

advisor

global institute of regulatory affairs

2013-1 - 2013-1 · 1 mo

designing curriculum for regulatory studies, training the trainers, assessment of course work, problem resolution , introduction to new regulatory updates, authoring course material , question based learning of regulations, publication of short articles, question based reviews of regulations

r and d manager

enzochem lab

1981-1 - 1984-1 · 3 yrs 1 mo

Development of Biochemicals, Industrial Enzyme and Pharmaceutical Products , Regulatory Compliance , QC/QA support to the Management

production executive

haffkine biopharmaceutical corporation mumbai

1977-1 - 1978-1 · 1 yr 1 mo

Production of Parenteral and Biological Products for Human Use

director

perfect pharmaceutical consultant

1990-1 - Present · 36 yrs 9 mos

managing director

perfect pharmaceutical consultants

1987-6 - Present · 39 yrs 4 mos

* Regulatory documents for a wide range of bulk drugs, pharmaceutical dosage forms, biological, Excipients and packaging materials * ACTD , CTD ,eCTD ,US & Canadian DMF Type II , III and IV * cGMP Audits, Vendor Audits * Assistance for Product Development Plan * Development of overall regulatory strategy * Review of preclinical pharmacology/toxicology studies/Clinical Studies * Review of Chemistry, Manufacturing, & Control studies * GMP Audits, Gap analysis , Vendor Audits

Education

haffkine institute

pr kmk college of pharmacy

pharmacy

1972-1 - 1975-1 · 3 yrs 1 mo

I achieved my Bachelor of Pharmacy Degree with First Class Honours Activities and Societies: Technical Seminar Team, Project Teams, Education Team

haffkine institute, mumbai, india

1975-1 - 1977-1 · 2 yrs 1 mo

Continuous Education Program and Career Advise for Pharmacy Students Social Activities such as Medical Assistance to Social Groups, Tree Plantation Activities and Societies: Professional advise and consultation on Regulatory Affairs, DMF,CTD,eCTD,CEP and ANDA , GMP Audits, GMP and Regulatory Training Indian Pharmaceutical Association Indian Drug Manufacturers Association Pharmexcil