Aakashdeep Raval

40 Followers

Highly energetic, task oriented pharmaceutical professional with keen knowledge in regulatory affairs and actively seeking for job oppertunities in Regulatory Affairs in Pharma/Biotech Companies around Ahmedabad. I have completed B.Pharm from L. J. Institute of Pharmacy and cleared my M.Pharm (Quality Assurance and Pharm Regulatory Affairs) from the same, L. J. Institute of Pharmacy with Distinction. I am now seeking for job as Regulatory affairs professional. I am a self-motivated, proactive individual with profound knowledge in Regulatory Affairs. Clinical Research and Quality Assurance for drugs, biologics and medical devices. I have a voracious capacity to learn new concepts, have t...

comparision of labelling requirements clinical trial protocol

Activity
About

Preparation of Clinical Trial Protocol of India.

8 years ago • 13762 Views

To prepare & compare Label, prescribing Information & Patient Information leaflet of REYATAZ (Hard Gelatin Capsule)

8 years ago • 546 Views

To compare filing process of NDA of different countries of India, US and Europe. B) Preparation of global list documents of registration of IND and NDA as per USFDA and Europe.

8 years ago • 2937 Views

(A) TO PREPARE AN APPLICATION FOR IND SUBMISSION FOR AZILSARTAN TABLET IN USA. (B) TO PREPARE CHECKLIST FOR AZILSARTAN TABLET AS PER USA.

8 years ago • 649 Views

5. A) To prepare an application for IND submission for Clobazam Tablet in US. B) To prepare IND checklist in us for Clobazam Tablet.

8 years ago • 468 Views

6. (A) To prepare an application for NDA submission for LAMICTAL in USA. (B) To prepare NDA checklist for LAMICTAL Tablet in USA.

8 years ago • 586 Views

To perform Analytical method validation of Paracetamol Tablets by UV-spectrophotometric method.

8 years ago • 23480 Views

To perform Analytical method validation of Paracetamol and Ibuprofen in pure and tablet form by UV spectrometric method.

8 years ago • 15187 Views

(A) To prepare an application for NDA submission for Telaprevir in USA. (B) To prepare NDA checklist for Telaprevir Tablet in USA.

8 years ago • 610 Views

Aakashdeep Raval

Documents

Preparation of Clinical Trial Protocol of India.

To prepare & compare Label, prescribing Information & Patient Information leaflet of REYATAZ (Hard Gelatin Capsule)

To compare filing process of NDA of different countries of India, US and Europe. B) Preparation of global list documents of registration of IND and NDA as per USFDA and Europe.

(A) TO PREPARE AN APPLICATION FOR IND SUBMISSION FOR AZILSARTAN TABLET IN USA. (B) TO PREPARE CHECKLIST FOR AZILSARTAN TABLET AS PER USA.

5. A) To prepare an application for IND submission for Clobazam Tablet in US. B) To prepare IND checklist in us for Clobazam Tablet.

6. (A) To prepare an application for NDA submission for LAMICTAL in USA. (B) To prepare NDA checklist for LAMICTAL Tablet in USA.

To perform Analytical method validation of Paracetamol Tablets by UV-spectrophotometric method.

To perform Analytical method validation of Paracetamol and Ibuprofen in pure and tablet form by UV spectrometric method.

(A) To prepare an application for NDA submission for Telaprevir in USA. (B) To prepare NDA checklist for Telaprevir Tablet in USA.

To prepare an application for manufacturing license for allopathic drugs in India.

Formal Meetings between the FDA and Sponsors or Applicants

To compare GMP requirement of India, US and Europe for tablets.

A) Study in detail about Para - IV filing. B) Case studies for Para - IV Filing.

Study of Marketing Conditions for Marketing Authorization of Over The Counter (OTC) and Homeopathic Products in US.

Comparison of Clinical Trial Application requirement of India, USA and Europe.