Pharmaceutical Regulatory science Unit:- 1 Notes
| Unit No | Unit Topic List | Download Link |
| 1 | New Drug Discovery and development | Click Here |
| 1 | New Drug Discovery and development | Click Here |
| 1 | Stages of drug discovery | Click Here |
| 1 | Concept of generics | Click Hear |
Pharmaceutical Regulatory science Unit:- 2 Notes
| Unit No | Unit Topic List | Download Link |
| 2 | Regulatory Approval Process | Click Here |
| 2 | Regulatory authorities and agencies | Click Here |
| 2 | New Drug Application (NDA) | Click Here |
| 2 | Abbreviated New Drug Application (ANDA) | Click Here |
| 2 | Regulatory authority body of Australia | Click Here |
| 2 | Regulatory requirements of EU,MHRA,TGA AND ROW COUNTRIES | Click Here |
Pharmaceutical Regulatory science Unit:- 3 Notes
| Unit No | Unit Topic List | Download Link |
| 3 | Common Technical Document (CTD) | Click Here |
| 3 | Common Technical Document (CTD) | Click Here |
| 3 | electronic Common Technical Document (eCTD) | Click Here |
| 3 | electronic Common Technical Document (eCTD) | Click Here |
| 3 | ASEAN Common Technical Document (ACTD) | Click Here |
Pharmaceutical Regulatory science Unit:- 4 Notes
| Unit No | Unit Topic List | Download Link |
| 4 | Clinical trials | Click Here |
| 4 | Developing clinical trial protocols | Click Here |
| 4 | Institutional Review Board / Independent Ethics committee – formation and working procedures | Click Here |
| 4 | Informed consent process and procedures | Click Here |
| 4 | Dossier, Impd and Ib | Click Here |
| 4 | Investigation of medicinal products dossier(IMPD) | Click Here |
| 4 | INVESTIGATOR BROCHURE | Click Here |
Pharmaceutical Regulatory science Unit:- 5 Notes
| Unit No | Unit Topic List | Download Link |
| 5 | Regulatory Concepts | Click Here |
| 5 | Basic terminology, guidance, guidelines, regulations, Laws and Acts | Click Here |
| 5 | Code of Federal Regulatory | Click Here |
| 5 | HIPAA- Health insurance portability and accountability act | Click Here |
Pharmaceutical Regulatory science
| Category | Resource Description | Download Link |
| Book | Regulatory science Book PDF Download | Click Here |
| Seminar | SEMINAR ON REGULATORY AFFAIRS PDF | PPT | Click Here |
