Cipla Opening !!!!Regulatory Affairs – Regulated Markets

28th February, 2014 - Posted by Sumit - No Comments

Regulatory affairs for regulated market (Australia,New Zealand).Dossier filing,handling submissions.Should have worked on regulated market. Experience Required – 1-3 years Location – Mumbai Desired Profile  - Should have good verbal & written communication skills  with positive attitude – Ability to grasp skills,learn new regulation requirements. – represent team in group discussion Contact Details Recruiter Name:Aparna Nandy Contact Company:Cipla Ltd […] Share this:LinkedInFacebook Read More

New Circular by Government of India for Online Registration

27th February, 2014 - Posted by Sumit - No Comments

Government of India has launched a web enabled system of Online Registration & submission of Online returns by the manufacturers & wholesalers of Psychotropic substance. The System is being implemented to facilitate registration of manufacturers & wholesalers of Psychotropic substance (bulk as well as preparation) in the country to get registered, to submit import/export application & quarterly […] Share this:LinkedInFacebook Read More

Role of RA in Product Life Cycle

21st February, 2014 - Posted by Rahul Agarwal - No Comments

This Diagrammatic Representation represents the Core role and Functions of RA, in the whole Product Life Cycle….i.e. Right from R &D to Post Marketing of the Product…!!!!!! Share this:LinkedInFacebook Read More

Regulatory Affairs Jobs………

21st February, 2014 - Posted by Sumit - No Comments

  if you are interested in doing a job or looking for a change in Pharmaceutical Field Regulatory Affairs Quality Assurance Quality Control Please send your resumes to info@regulatoryinstitute.com   or for details please fill up the form and we will contact you. GIRA offers training programs in Quality Assurance- Quality Control  - Regulatory Affairs […] Share this:LinkedInFacebook Read More

Regulatory Job @ Dr. reddy’s

21st February, 2014 - Posted by Rahul Agarwal - No Comments

Job Post: Clinical Regulatory Compliance (CRC)- Executive Experience: 1-3 yrs Location: Hyd/ Secunderabad Link: http://jobsearch.naukri.com/job-listings-Clinical-Regulatory-Compliance-crc-Executive-Dr-Reddys-Laboratories-Ltd–Hyderabad-Secunderabad-1-to-3-190214001114?xz=1_0_3&xo=&xp=1&xid=139279868021548400&qjt=&qp=Dr.+reddys&id=&f=-190214001114 Share this:LinkedInFacebook Read More

New Circular for Fixed Dose Combination

19th February, 2014 - Posted by Sumit - No Comments

DCGI has issued a new circular on 3rd Feb regarding Fixed Dose Combinations For all FDCs approved by the State licensing authority without prior approval from DCGI were requested to submit data to prove Safety and Efficacy of in timely and prescribed manner. In the view of the same CDSCO has requested all applicants to provide […] Share this:LinkedInFacebook Read More

FDA surprise checks on, but DCGI will be kept in loop

17th February, 2014 - Posted by Sumit - No Comments

“”An statement of intent signed between Union health secretary Keshav Desiraju and FDA commissioner Margaret Hamburg on Monday, regulators need to inform “the respective regulatory authorities before undertaking inspections so that host-country inspectors may join inspections as observers”.”” This means any surprise audit or audit undertaken by US FDA in India will be informed to […] Share this:LinkedInFacebook Read More

Regulatory Affairs Survey Summary- Conducted by RAPS

6th February, 2014 - Posted by Sumit - No Comments

Key findings/summary as per Survey conducted by RAPS in 2012 for regulatory affairs Professionals, Professionals Working in Research & development , Quality Assurance & Control tend to go ahead and work in Regulatory affairs or make regulatory affairs as their career Around 73% Regulatory affairs Professional work in Industry while the remaining work in allied […] Share this:LinkedInFacebook Read More

Mahesh Zagade – FDA Commissioner warns Chemist against mis-selling drugs.

3rd February, 2014 - Posted by Sumit - No Comments

FDA Maharashtra commissioner is appealing to chemist to spread awareness and to put patient safety on top while selling drugs. Maintain authentic prescription records i.e Name of Doctor & Hospital before selling any medicine Maintain copy of prescription in case of sedatives. He also appeal to the citizen to insist on counselling when buying over […] Share this:LinkedInFacebook Read More

DCGI issues New Pre –Screening Checklist for BA/BE Applications effective 1st Feb 14

3rd February, 2014 - Posted by Sumit - No Comments

DCGI has issued New Pre –Screening Checklist for BA/BE Applications on their website Effective From – This new Checklist will be effective from 1st February 2014 Major Change - An Application for BA/BE NOC for export purpose is now required to be filled even for old drugs ( Drugs which have been approved for more than 4 years […] Share this:LinkedInFacebook Read More