Distance Learning

This programme is offered keeping in mind, professionals who are not able to attend the classroom sessions. Also, people who are residing out of Mumbai & India can also gain the advantage of Distance learning courses.

Salient features are:

  • Admissions open for all 365 days
  • Webinar sessions on 4-5 key topics by experienced industrial faculties
  • User-friendly notes based on current guidelines.
  • Time flexibility for attending assessments
  • Question bank based on common interview questions
  • Certification after course completion

Course execution:

    • Course will commence after completion of the admission formalities.
    • Notes & CD containing relevant guidelines & formats will be couriered in 2 weeks time.
    • Presentations and important questions will be emailed.
    • Students can listen to the webinar sessions on important RA topics
    • Queries can be emailed.

– For students residing in Mumbai- assessment will be conducted at IPM, Dombivli, and grade will be allotted

– For students residing outside Maharashtra/ India, assignments will be given and
additional on-line interviews will be conducted

PG Diploma in Regulatory Affairs(API & Formulation)

Eligibility: Pharma/Science graduates and Post-graduates/ Industry working professionals

Duration: 6 months

Course Highlights:
Pharmaceutical Quality System, Indian Pharmaceutical Industry
Regulatory Affairs, Overview of GMP,
Registration requirements of USFDA
ICH Quality guidelines
ICH M4 Q CTD format

DMF preparation: Module 2, Module 3

Regulatory Submission to US

  • DMF submission, Common deficiencies, Handling changes

Regulatory submission to Europe

  • CEP approval, Module 1, 2 & 3
  • Addressing deficiencies, Revisions & renewal

WHO, Canada, Japan filing procedures
Dossier preparation in CTD format: Module 2, 3, 4 & 5

Regulatory Submission to US, ANDA approval process, Hatch-Waxman Law

Regulatory Submission to Europe- Marketing Authorisation procedures

  • Module 1 & 2, Common deficiencies, Variations

Regulatory Submission to Semi Regulated Markets

  • Latin America (Brazil & Mexico)
  • ACTD submission, Regulatory Submission to India

eCTD Submissions