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USFDA Issues Guidance for Controlling Nitrosamine Impurities

WEBPosted September 03, 2020 | By Pallab Roy. N-nitrosamine (hereinafter referred to as “nitrosamine”) has been classified as probably carcinogenic to humans by the World …

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URL: https://aariya.net/2020/09/03/usfda-issues-guidance-for-controlling-nitrosamine-impurities-in-human-drugs/

USFDA Issues Draft Guidance to Assist Applicants Respond to an …

WEBPosted September 29, 2020 | By Pallab Roy. Yesterday, the USFDA announced the availability of a draft guidance for industry entitled “Failure to Respond to an ANDA …

Category: Health Go Health

USFDA Issues Guidance to Address Regulatory Questions

WEBIn USFDA’s ongoing bid to support response efforts to the Coronavirus Disease 2019 (COVID-19), on May 26, 2020, the agency issued an immediately …

Category: Coronavirus Go Health

TGA Publishes Guide on Submitting Data in eCTD Format

WEBPosted July 09, 2020 | By Pallab Roy. On July 6, 2020, Therapeutic Goods Administration (TGA) published a step-by-step guide on submitting an electronic Common Technical …

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Health Science Authority (HSA), Singapore Updates Guidance on

WEBPosted January 04, 2021 | By Pallab Roy. As part of Health Science Authority (HSA), Singapore’s ongoing initiative to streamline the regulatory controls for health products, …

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Health Canada Starts Accepting Drug Information in the XML

WEBPosted April 24, 2020 | By Pallab Roy. Back in 2016, when Health Canada for the first time informally announced its thought process on adopting the ISO standard, Identification of …

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About Us Aariya Regulatory Services Pvt Ltd

WEBAariya Regulatory Services Pvt Ltd. The increasingly complex requirements of health authorities, coupled with a need to remain abreast of the rapidly evolving global …

Category: Health Go Health

HA Queries – Responses Aariya Regulatory Services Pvt Ltd

WEBHealth Authority (HA) Queries - Responses. AARIYA has a proven track record in handling HA queries for speedy approval and uninterrupted commercialization of a product …

Category: Health Go Health

New Product Authorizations Services Aariya Regulatory Services …

WEBA well-prepared regulatory application can translate into a smoother approval process and faster entry to the market. AARIYA has a globally recognized Center of Excellence in …

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Regulatory Operations CMC Services

WEBRegulatory Operations – Chemistry, Manufacturing and Controls (CMC): Whatever your product, no pharmaceutical regulatory affairs consultancy knows the CMC process …

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Regulatory Consulting Services Aariya Regulatory Services Pvt Ltd

WEBWe believe in Customer service excellence, Uncompromising quality, Ethics and integrity. Aariya’s seamless support in arranging quality labeling, technical inputs, quality review, …

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eCTD Best Practices to Attain Quality Submission

WEBPosted June 16, 2020 | By Oindrila Ghosal. The electronic Common Technical Document (eCTD) publishing has become the international specification for pharmaceutical …

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Health Science Authority (HSA), Singapore Announces New Post

WEBOn May 6, 2020, Singapore’s Health Science Authority (HSA) announced a new pilot program to prospectively publish Summary Reports of Benefit-Risk Assessments for …

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MHRA Publishes Post-transition Period Regulations for Clinical

WEBPosted September 11, 2020 | By Pallab Roy. The UK has left the EU, and the transition period after Brexit comes to an end this year. Transition from the EU allows the UK to …

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Philippines FDA Announces Accelerated Registration Process for …

WEBPosted August 06, 2020 | By Pallab Roy. The Food and Drug Administration, Philippines has released a draft proposal to provide an accelerated review process for prequalified …

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NPRA, MOH Malaysia Offers Pre-Submission Meeting (PSM) …

WEBData required to prepare a submission dossier is complex and attention to minute details of requirements is important to ensure a smooth assessment process. …

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WHO Seeks Recommendations for Regulatory Reliance

WEBThe World Health Organisation (WHO) has recently began seeking public consultation on recommendations for good reliance practices (GRelP) which aims at …

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COVID-19 Pandemic: USFDA Issues Advisory for ANDA Applicants …

WEBIn USFDA’s ongoing bid to support continuity and response efforts to the Coronavirus Disease 2019 (COVID-19), on April 28, 2020, the agency issued an …

Category: Coronavirus Go Health