Hermine Takhtalyan, experienced QA specialist with a demonstrated history of working in pharmaceuticals industry.Skilled in Elemental impurities risk assessment, Nitrosamine impurities risk assessment, extractables and leachables risk assessment,DNA reactive (mutagenic) impurities risk assessment. First in Eurasian Economic Union (EAEU) implemented Elementsl impurities risk assessment and Nitrosamine impurities risk assessment.
Thank you very much. I am glad to join this scientific expert group dealing with Nitrosamines issues.
Hello to every one in this group.
My names are Felchism Apolnary, Pharmacist with Masters degree in Biotechnology Innovation and Regulatory Science.
I working with Medicines Regulatory Authority of Tanzania (TMDA). Technically I am assessor of medicinal product dossiers.
I should also mention that I am a WHO consultant/technical advisor participating in the WHO – Prequalification Team - Medicines for assessment for Active Pharmaceutical Ingredient (API).
Thanks
@Felchism1 Welcome to Nitrosamine Exchange. I hope you find this community helpful and insightful as you progress your Nitrosamine journey.
Feel free to participate in the discussions that we host on daily basis, and share information that you find could benefit the community.
Welcome!
@Hermine401 Welcome to Nitrosamine Exchange Community. Your experience on Nitrosamines Risk Assessment will be invaluable for all the discussions we host here. Please feel free to reply and provide your expert views on the community.
Welcome!
@DPandey Welcome to Nitrosamine Exchange. The hunt for a robust analytical method is a daily quest here in the community. Your experience and insight are more than welcome in any of our analytical discussions, so feel free to participate and hit reply when you see necessary. You have now thousands of chemists working on similar challenges that you and your team are facing!
Welcome
Hello everyone. I am Dr. Kiran, working as a senior manager in MSN Laboratories in API R&D department since 10 years. I am very glad to be part of this scientific community. Looking ahead for an active participation with you all.
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Hi, My name is Nagendar Reddy Purmandla. I am working at Honour R&D facility a Hetero group of company, Hyderabad, India. I have total experience of 22years in Analytical development, especially on Mass and NMR spectrometry and working on GTI’s and NDSRI of our API and DP . Happy to be part of this group.
Hello Everyone,
I am Vivek Dubey, serving as a Senior Scientist at Daicel Chiral Technologies in Hyderabad, bringing with me 16 years of expertise in the Analytical field. My primary focus lies in characterization, with the past 4 years dedicated to assessing Nitrosamine Impurities in API and Drug products.
I am delighted to join this community, eager to both learn and contribute.
Best regards,
Vivek
Hola, mi nombre es Marleby García y soy Bioquímica. Mi trabajo es estar al frente de pruebas de cuantificación de nitrosaminas en México siguiendo la farmacopea mexicana. Tenemos 2 métodos analíticos validados con alcance a 6 nitrosaminas. Hemos evaluado sartanes, metformina entre otros.
Hello, my name is Marcin Kublicki and I am an organic chemist. I have been working for the last 4 years in the pharmaceutical consulting company SciencePharma as a CMC consultant. Aside from nitrosamine risk assessments, I work on pharmaceutical dossier gap reports, technical documentation of medical devices, genotoxicity assessments.
This scientific community has been an invaluable help in my work and I am very glad to be a part of it.
Best regards,
Marcin
Hi everyone,
My name is Ken Meade. I’m a Compliance Specialist at Contract Pharmaceuticals Ltd. (CPL) in Canada. My company is a contract manufacturer of liquid and semi-solid drug products.
Preparation of nitrosamines risk assessments has been assigned to me. I have already learned a lot about nitrosamines through this forum, and I hope to continue getting great advice from the many experts here.
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Hi
I am Onyeodili Isdore, a QAM in a Pharma industry for almost a year now.
Hoping to learning new things.
Good morning Mr. Naiffer,
Thank you for accepting my request. I’m very happy and excited to be a part of this group. I Dr. Divakara LS Nori, working as R&D Scientist in pharmazell India private Limited, an axplora company. My role is process development of APIs by evaluation of GTI and Nitrosamines. I have 21 years of experience in the field of R&D, Discovery and CDMO. I have been nominated to focus more on the topic of Nitrosamines, NDSRI’s by Management and I’m looking forward to gaining some good knowledge from all the experts of this group. Thank you once again. With Best Regards