Submit Search
Upload
CMC Logistics
•
Download as PPT, PDF
•
6 likes
•
1,539 views
L
lsovalova
Follow
Details format and content requirements for CMC part of a requlatory submission
Read less
Read more
Report
Share
Report
Share
1 of 34
Download now
Recommended
Supac
Supac
Dr. Jigar Vyas
Sampling in process validation
Sampling in process validation
Salum Mkata
Ich guideline quality
Ich guideline quality
rupu2131
ICH Guidlines for stability studies
ICH Guidlines for stability studies
Vishnu Satpute
Ich guidelines and protocols
Ich guidelines and protocols
ceutics1315
Preparing an IND Application: CMC
Preparing an IND Application: CMC
MaRS Discovery District
Q1 d step4
Q1 d step4
Pharmaguideline
Ich Guidelines Au. Vivek Jain
Ich Guidelines Au. Vivek Jain
Vivek Jain
Recommended
Supac
Supac
Dr. Jigar Vyas
Sampling in process validation
Sampling in process validation
Salum Mkata
Ich guideline quality
Ich guideline quality
rupu2131
ICH Guidlines for stability studies
ICH Guidlines for stability studies
Vishnu Satpute
Ich guidelines and protocols
Ich guidelines and protocols
ceutics1315
Preparing an IND Application: CMC
Preparing an IND Application: CMC
MaRS Discovery District
Q1 d step4
Q1 d step4
Pharmaguideline
Ich Guidelines Au. Vivek Jain
Ich Guidelines Au. Vivek Jain
Vivek Jain
Comparison of stability testing requirements of ich with other
Comparison of stability testing requirements of ich with other
Jun Brown
Process validation
Process validation
Dr. Jigar Vyas
CGMP for IND phase I products
CGMP for IND phase I products
GMP EDUCATION : Not for Profit Organization
ICH Stability testing of new drug substances and products QA (R2) - 2015
ICH Stability testing of new drug substances and products QA (R2) - 2015
Pharmaceutical Compliance Inspection unit, Crown College of Canada
Ich guidlines q and s
Ich guidlines q and s
Bashant Kumar sah
Presentation on ICH guidelines Q5A (R1) and Q4B Annex 2 (R1)
Presentation on ICH guidelines Q5A (R1) and Q4B Annex 2 (R1)
HadiaNaz1
Ich guidelines
Ich guidelines
Malla Reddy College of Pharmacy
ICH guidelines
ICH guidelines
Manjit Kaur
ICH guidelines
ICH guidelines
Mayur Bodhankar
Stability testing of herbal natural products and its
Stability testing of herbal natural products and its
SudhindraKini
Scale up process and post marketing survilence
Scale up process and post marketing survilence
KAVITAAGRE
ICH Q6A & ICH Q7
ICH Q6A & ICH Q7
Maulik Malvania
Impurities ICH Q3 Guidelines Au Vivek Jain
Impurities ICH Q3 Guidelines Au Vivek Jain
Vivek Jain
ICH Q3B (R2):Impurities in new drug products
ICH Q3B (R2):Impurities in new drug products
Vinit Gohel
Bulk active post approval changes
Bulk active post approval changes
bdvfgbdhg
ANDA Stability Requirements
ANDA Stability Requirements
GMP EDUCATION : Not for Profit Organization
Ich q8 ppt
Ich q8 ppt
Palakdeep kaur(Parmeshar)
Pharmaceutical development report (pdr)
Pharmaceutical development report (pdr)
Atul Bhombe
Supac
Supac
Malla Reddy College of Pharmacy
Ich guidelines Q1A(R2)
Ich guidelines Q1A(R2)
Surendra Singh
Regulatory affairs cmc , post approval regulatory affairs
Regulatory affairs cmc , post approval regulatory affairs
ArjunDhawale
NEW DRUG APPLICATION (NDA).pptx
NEW DRUG APPLICATION (NDA).pptx
AmitSahu546305
More Related Content
What's hot
Comparison of stability testing requirements of ich with other
Comparison of stability testing requirements of ich with other
Jun Brown
Process validation
Process validation
Dr. Jigar Vyas
CGMP for IND phase I products
CGMP for IND phase I products
GMP EDUCATION : Not for Profit Organization
ICH Stability testing of new drug substances and products QA (R2) - 2015
ICH Stability testing of new drug substances and products QA (R2) - 2015
Pharmaceutical Compliance Inspection unit, Crown College of Canada
Ich guidlines q and s
Ich guidlines q and s
Bashant Kumar sah
Presentation on ICH guidelines Q5A (R1) and Q4B Annex 2 (R1)
Presentation on ICH guidelines Q5A (R1) and Q4B Annex 2 (R1)
HadiaNaz1
Ich guidelines
Ich guidelines
Malla Reddy College of Pharmacy
ICH guidelines
ICH guidelines
Manjit Kaur
ICH guidelines
ICH guidelines
Mayur Bodhankar
Stability testing of herbal natural products and its
Stability testing of herbal natural products and its
SudhindraKini
Scale up process and post marketing survilence
Scale up process and post marketing survilence
KAVITAAGRE
ICH Q6A & ICH Q7
ICH Q6A & ICH Q7
Maulik Malvania
Impurities ICH Q3 Guidelines Au Vivek Jain
Impurities ICH Q3 Guidelines Au Vivek Jain
Vivek Jain
ICH Q3B (R2):Impurities in new drug products
ICH Q3B (R2):Impurities in new drug products
Vinit Gohel
Bulk active post approval changes
Bulk active post approval changes
bdvfgbdhg
ANDA Stability Requirements
ANDA Stability Requirements
GMP EDUCATION : Not for Profit Organization
Ich q8 ppt
Ich q8 ppt
Palakdeep kaur(Parmeshar)
Pharmaceutical development report (pdr)
Pharmaceutical development report (pdr)
Atul Bhombe
Supac
Supac
Malla Reddy College of Pharmacy
Ich guidelines Q1A(R2)
Ich guidelines Q1A(R2)
Surendra Singh
What's hot
(20)
Comparison of stability testing requirements of ich with other
Comparison of stability testing requirements of ich with other
Process validation
Process validation
CGMP for IND phase I products
CGMP for IND phase I products
ICH Stability testing of new drug substances and products QA (R2) - 2015
ICH Stability testing of new drug substances and products QA (R2) - 2015
Ich guidlines q and s
Ich guidlines q and s
Presentation on ICH guidelines Q5A (R1) and Q4B Annex 2 (R1)
Presentation on ICH guidelines Q5A (R1) and Q4B Annex 2 (R1)
Ich guidelines
Ich guidelines
ICH guidelines
ICH guidelines
ICH guidelines
ICH guidelines
Stability testing of herbal natural products and its
Stability testing of herbal natural products and its
Scale up process and post marketing survilence
Scale up process and post marketing survilence
ICH Q6A & ICH Q7
ICH Q6A & ICH Q7
Impurities ICH Q3 Guidelines Au Vivek Jain
Impurities ICH Q3 Guidelines Au Vivek Jain
ICH Q3B (R2):Impurities in new drug products
ICH Q3B (R2):Impurities in new drug products
Bulk active post approval changes
Bulk active post approval changes
ANDA Stability Requirements
ANDA Stability Requirements
Ich q8 ppt
Ich q8 ppt
Pharmaceutical development report (pdr)
Pharmaceutical development report (pdr)
Supac
Supac
Ich guidelines Q1A(R2)
Ich guidelines Q1A(R2)
Similar to CMC Logistics
Regulatory affairs cmc , post approval regulatory affairs
Regulatory affairs cmc , post approval regulatory affairs
ArjunDhawale
NEW DRUG APPLICATION (NDA).pptx
NEW DRUG APPLICATION (NDA).pptx
AmitSahu546305
ICH guidelines on impurities in new drug products.pptx
ICH guidelines on impurities in new drug products.pptx
Divya Pushp
CMC, post approval regulatory affairs, etc
CMC, post approval regulatory affairs, etc
JayeshRajput7
NEW DRUG APPLICATION ( NDA)
NEW DRUG APPLICATION ( NDA)
Suvarta Maru
Health Canada guidance for biotechnology products - Professor Peivand Pirouzi
Health Canada guidance for biotechnology products - Professor Peivand Pirouzi
Pharmaceutical Compliance Inspection unit, Crown College of Canada
Specification: Test procedure and acceptance criteria
Specification: Test procedure and acceptance criteria
DigeshPatel17
Q5C.ppt
Q5C.ppt
Kalakonda Sri Nataraj
Dr. Abhijath's RA Document (CMC, Post Approvals, Regulation of Combination Pr...
Dr. Abhijath's RA Document (CMC, Post Approvals, Regulation of Combination Pr...
Abhijath Murali
industrial prespectives of IND
industrial prespectives of IND
Ravi Kumar katukuri
Q6 guidelines
Q6 guidelines
Anjali Aji
REGULATORY REQUIREMENTS IN ROW.pptx
REGULATORY REQUIREMENTS IN ROW.pptx
JeelJoshi8
NEW DRUG APPLICATION
NEW DRUG APPLICATION
SACHIN C P
GENERIC DRUG PRODUCT DEVELOPMENT.pptx
GENERIC DRUG PRODUCT DEVELOPMENT.pptx
Kishor Singha
Q3 B R2 ICH Guideline
Q3 B R2 ICH Guideline
Mahesh Chokshi
GMP Sub Part H, I & J
GMP Sub Part H, I & J
HARDIK PATEL
Ich guidelines and protocols
Ich guidelines and protocols
Malla Reddy College of Pharmacy
Q3 b r2_ step4
Q3 b r2_ step4
Pharmaguideline
akshay regulatory seminar 1 productregistrationanddrugapprovalprocessinus.ppt
akshay regulatory seminar 1 productregistrationanddrugapprovalprocessinus.ppt
GaneshSureshKumbhar
ABBREVIATED NEW DRUG APPLICATION (ANDA) by Anthony crasto
ABBREVIATED NEW DRUG APPLICATION (ANDA) by Anthony crasto
Anthony Melvin Crasto Ph.D
Similar to CMC Logistics
(20)
Regulatory affairs cmc , post approval regulatory affairs
Regulatory affairs cmc , post approval regulatory affairs
NEW DRUG APPLICATION (NDA).pptx
NEW DRUG APPLICATION (NDA).pptx
ICH guidelines on impurities in new drug products.pptx
ICH guidelines on impurities in new drug products.pptx
CMC, post approval regulatory affairs, etc
CMC, post approval regulatory affairs, etc
NEW DRUG APPLICATION ( NDA)
NEW DRUG APPLICATION ( NDA)
Health Canada guidance for biotechnology products - Professor Peivand Pirouzi
Health Canada guidance for biotechnology products - Professor Peivand Pirouzi
Specification: Test procedure and acceptance criteria
Specification: Test procedure and acceptance criteria
Q5C.ppt
Q5C.ppt
Dr. Abhijath's RA Document (CMC, Post Approvals, Regulation of Combination Pr...
Dr. Abhijath's RA Document (CMC, Post Approvals, Regulation of Combination Pr...
industrial prespectives of IND
industrial prespectives of IND
Q6 guidelines
Q6 guidelines
REGULATORY REQUIREMENTS IN ROW.pptx
REGULATORY REQUIREMENTS IN ROW.pptx
NEW DRUG APPLICATION
NEW DRUG APPLICATION
GENERIC DRUG PRODUCT DEVELOPMENT.pptx
GENERIC DRUG PRODUCT DEVELOPMENT.pptx
Q3 B R2 ICH Guideline
Q3 B R2 ICH Guideline
GMP Sub Part H, I & J
GMP Sub Part H, I & J
Ich guidelines and protocols
Ich guidelines and protocols
Q3 b r2_ step4
Q3 b r2_ step4
akshay regulatory seminar 1 productregistrationanddrugapprovalprocessinus.ppt
akshay regulatory seminar 1 productregistrationanddrugapprovalprocessinus.ppt
ABBREVIATED NEW DRUG APPLICATION (ANDA) by Anthony crasto
ABBREVIATED NEW DRUG APPLICATION (ANDA) by Anthony crasto
CMC Logistics
1.
2.
3.
STAGES OF DRUG
APPROVAL by FDA
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
Download now