Search Results for "fda submissions"

Found 147 presentations matching your search

US FDA Regulatory Submissions

US FDA Regulatory Submissions

Basic information for beginners...

29 slides 3,605
General
US FDA 510(k) Submission Services for Medical Devices & IVDs

US FDA 510(k) Submission Services for Medical Devices & IVDs

Get expert support for US FDA 510(k) approval. Our team guides you through Traditional, Special, and...

8 slides 2
Technology
avajosheph
Artixio MedTech Training Brochure 2023.pdf

Artixio MedTech Training Brochure 2023.pdf

Product Technical Documents for Regulatory Submissions Regulatory Submissions - US FDA Regulatory Su...

7 slides 24
Technology
YYogiRaj1
FDA Guidance Documents

FDA Guidance Documents

If you are in the Life Sciences Industry you have heard of FDA Guidance Documents, and specifically,...

1 slides 84
Design
EMMAIntl
Security Architecture Views the FDA Expects — And How to Get Them Right

Security Architecture Views the FDA Expects — And How to Get Them Right

Architectural views play a pivotal role in demonstrating the cybersecurity posture of a medical devi...

27 slides 1
Business
ICSinc
How to Submit Non-Clinical Data to CBER Using SEND : Understanding New FDA Requirements.pptx

How to Submit Non-Clinical Data to CBER Using SEND : Understanding New FDA Requirements.pptx

What You Will Learn The FDA’s CBER will begin requiring electronic submissions of nonclinical dat...

38 slides 912
Healthcare
THERAPEUTIC GOODS ADMINISTRATION(TGA) - dive into Regulatory affairs and its regulations Pharma guidance

THERAPEUTIC GOODS ADMINISTRATION(TGA) - dive into Regulatory affairs and its regulations Pharma guidance

This presentation provides a comprehensive overview of TGA (Therapeutic Goods Administration) regula...

88 slides 55
Business
Ayushijain362
ANDA Submission.pptx

ANDA Submission.pptx

Abbreviated New Drug Application (ANDA) Submission: Introduction Basic Generic Drug Requirements Goa...

30 slides 1,026
Technology
Dossier and Common Technical Document (CTD)

Dossier and Common Technical Document (CTD)

A dossier refers to a comprehensive collection of documents submitted to a regulatory authority to d...

19 slides 461
Healthcare
CDISC Electronic Submission to FDA

CDISC Electronic Submission to FDA

According to FDA Draft Guidance for Industry in Electronic Submission and Study Data Technical Confo...

29 slides 4,590
General
KevinLee56
communication in pharmacovigilance for B pharmacy and Pharm D

communication in pharmacovigilance for B pharmacy and Pharm D

communication in pharmacovigilance pharmacovigilance for B pharmacy and pharm D

14 slides 3,063
Healthcare
Data Presentation for FDA Submission ppt.pptx

Data Presentation for FDA Submission ppt.pptx

The ideas in this chapter for improving the text and the tables in NDA submissions (or other regulat...

18 slides 2,911
General
Drug master file

Drug master file

A topic from QCQA which is documentary work for pharmaceutical drug substance and drug products. Thi...

22 slides 26,911
General
Reimbursement Bootcamp- Coding, Coverage & Payment lecture by David Farber, King & Spalding

Reimbursement Bootcamp- Coding, Coverage & Payment lecture by David Farber, King & Spalding

Presentation by David Farber, King & Spalding LLP, "Reimbursement Bootcamp- Coding, Coverag...

46 slides 438
Healthcare
levshapiro
API, BIOLOGICS,NOVEL,THERAPIES........pptx

API, BIOLOGICS,NOVEL,THERAPIES........pptx

Topics: REGULATORY REQUIREMENT FOR APPROVAL OF API, BIOLOGICS, NOVEL DRUGS AND NDA Prepared B...

32 slides 11,297
Design
PawanDhamala1
21 CFR part 11

21 CFR part 11

21 CFR is reserved for rules of the FOOD and DRUG ADMINISTRATION (FDA) It is divided into 3 Chapters...

10 slides 139
Healthcare
ClinosolIndia
INDA (INVESTIGATIONAL NEW DRUG APPLICATIONS)

INDA (INVESTIGATIONAL NEW DRUG APPLICATIONS)

INVESTGATIONAL NEW DRUG APPLICATIONS

28 slides 1,685
Technology
regulation of medical devices

regulation of medical devices

Medical device regulation is complex, in part because of the wide variety of items that are categori...

21 slides 1,071
Healthcare
KeerthanaN20
Difference european drug master file & us drug master file

Difference european drug master file & us drug master file

k

25 slides 4,261
General
dineshkumarprajapati583
Mechanical Testing for Medical Face Masksss

Mechanical Testing for Medical Face Masksss

Mechanical testing of Face Masks

19 slides 54
General
franklio2
ORA - A Day In the Life - Div. Recall Coordinator - Module 5.pptx

ORA - A Day In the Life - Div. Recall Coordinator - Module 5.pptx

recall procedure

38 slides 16
General
ssuser088c0d
CTD and eCTD Seminar.pptx

CTD and eCTD Seminar.pptx

It gives information about CTD and eCTD. Also, please learn about their similarities and differences...

23 slides 5,403
Technology
DMF Drug Master File

DMF Drug Master File

 DRUG MASTER FILE  Presented by :  RUSHIKESH D MENDHE  Roll no - 511  Mpharm Ist Year...

19 slides 22,357
Technology
Providing Submissions in Electronic Format-Post Marketing Safety Report

Providing Submissions in Electronic Format-Post Marketing Safety Report

Providing Submissions in Electronic Format — Post marketing Safety Reports

10 slides 20
Business
sbose2