Aakashdeep Raval

40 Seguidores

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

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Preparation of Clinical Trial Protocol of India.

Hace 8 años • 13762 Visualizaciones

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

Hace 8 años • 546 Visualizaciones

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.

Hace 8 años • 2937 Visualizaciones

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

Hace 8 años • 649 Visualizaciones

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

Hace 8 años • 468 Visualizaciones

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

Hace 8 años • 586 Visualizaciones

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

Hace 8 años • 23480 Visualizaciones

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

Hace 8 años • 15187 Visualizaciones

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

Hace 8 años • 610 Visualizaciones

Aakashdeep Raval

Documentos

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.