| (Published: Mon, 23 Jan 2023 06:07:09 +0000) |
| Essential Elements for Establishing Effective Medical Writing Documents |
| This article talks about the essential elements that medical device manufacturers should consider while establishing effective medical writing documents. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 23 Jan 2023 06:06:42 +0000) |
| Key Points to Prepare Clinical Evaluation Report CER under EU MDR 2017745 |
| This article talks about the key points to consider while preparing Clinical Evaluation Report (CER) under EU MDR 2017/745. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 23 Jan 2023 06:05:41 +0000) |
| eCTD Submissions Planning & Tracking for Successful Global eCTD Submissions |
| This article talks about the eCTD submissions planning & tracking for successful global eCTD submissions to comply with the various Health Authority (HA) timelines and regulations. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 23 Jan 2023 06:04:33 +0000) |
| US FDA Regulatory Approval Pathways for IVDs |
| This article talks about the US FDA regulatory approval pathways for successful registration of an In-Vitro diagnostics(IVDs). |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 23 Jan 2023 06:04:04 +0000) |
| USFDA guidance on Failure to Respond to an ANDA CRL |
| This article talks about the USFDA guidance on Failure to Respond to an ANDA Complete Response Letter (CRL) within the regulatory timeframe guidance for industry to ensure faster drug approval. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 23 Jan 2023 06:03:22 +0000) |
| Overview on FDA's Drug Competition Action Plan |
| This article talks about an overview on FDA's Drug Competition Action Plan (DCAP) to enhance the competition in generic drug development. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 23 Jan 2023 06:02:53 +0000) |
| USFDA Update on Cloud-based Regulatory Assessments |
| This article talks about the USFDA update on cloud-based regulatory assessments for dynamic exchange of information between the regulators and the industry. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 05 Jan 2023 07:57:49 +0000) |
| Adopting Pharmaceutical Aggregation as a Next Sensible Step Post Serialization |
| This article talks about the adopting pharmaceutical aggregation as a next sensible step post serialization to ensure patient safety and supply chain management.
Pharmaceutical aggregation, Regulatory Artwork Services, Serialization, Pharmaceuticals Artwork Management, Artwork Outsourcing, Artwork |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 05 Jan 2023 07:55:06 +0000) |
| An Overview of Cosmetic Labeling in the USA |
| This article talks about an overview of cosmetic labeling in the USA to comply with USFDA regulations. Cosmetic Labeling, USFDA, Regulatory Labeling, USFDA regulations, Labeling Claims |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 05 Jan 2023 07:54:35 +0000) |
| Important Elements to Consider in Class B Regulatory Lifecycle |
| This article talks about the important elements to consider in class B Regulatory Lifecycle in order to be compliant with the EU IVDR 2017/746 regulations. Medical Devices, Regulatory Affairs, EU IVDR, Regulations, IVDs, European Union, EU IVDR 2017/746, Regulatory Lifecycle, class B |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 05 Jan 2023 07:53:56 +0000) |
| Significance of Misbranding or Mislabeling in Medical Device Labeling |
| This article talks about the significance of misbranding or mislabeling in Medical Device Labeling. Medical Devices, Regulatory Affairs, Medical Device Labeling, Misbranding, labeling, Mislabeling |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 05 Jan 2023 07:48:41 +0000) |
| Overview on Japanās Economic Security Bill Act and itās Affect on the Pharmaceutical Industry |
| This article talks about the overview on Japanās economic security bill act and itās affect on the pharmaceutical industry. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 05 Jan 2023 07:48:01 +0000) |
| Benefits of Regulatory Affairs Staff Augmentation for Life Sciences Organizations |
| This article talks about theĀ benefits of regulatory affairs staff augmentation outsourcig for life sciences organizations.
Contract Staffing Partner, LifeSciences Industry, Regulatory Affairs Outsourcing, Regulatory Affairs Staff Augmentation, Regulatory Affairs, RA, Staffing Outsourcing |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 21 Dec 2022 06:21:44 +0000) |
| Medical Device Labeling Compliance Under 21 CFR Part 801 |
| This article talks about the guidelines to medical device labeling compliance under 21 CFR Part 801. Labeling is defined as the ādisplay of written, printed, or graphic matter upon the immediate container of any article.ā Any medication that is intended to be distributed must be labeled as per t |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 21 Dec 2022 06:21:13 +0000) |
| Regulation of Cosmetic Preservatives in the EU |
| This article talks about the use of preservatives in cosmetic products to comply with the EU Regulatory guidelines. Preservatives are used in cosmetic products to ensure their safety during their lifetime. As many cosmetics contain water, once exposed to the environment, they become prone to the gro |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 21 Dec 2022 06:19:29 +0000) |
| Challenges for Medical Writers to prepare an Investigatorās Brochure IB |
| This article talks about the challenges for medical writers to prepare an Investigatorās Brochure (IB). A comprehensive compilation of clinical and nonclinical data on the investigational product (drug, supplement, device, or other product) provides a brief description of the drug substance and th |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 21 Dec 2022 06:18:55 +0000) |
| US FDA Issued Warning Letters to Dietary Supplement Companies for False Claims |
| This article talks about the US FDA issued warning letters to dietary supplement companies for false claims. Marketing promotions and advertisements in Pharmaceuticals are information of nexus where research concepts are transformed into realistic therapeutic tools, and information is made useful fo |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 21 Dec 2022 06:18:16 +0000) |
| PMSR requirements under EU MDR and EU IVDR |
| This article talks about the PMSR (Post-Market Surveillance Report) requirements under EU MDR and EU IVDR. The importance of post-market surveillance (PMS) has never been out of the buzz. Regulatory Authorities worldwide have established some stringent rules and regulations to efficiently monitor me |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 21 Dec 2022 06:16:13 +0000) |
| Effective use of Universal Language Symbols in Medical Device Labeling |
| This article talks about the effective use of universal language symbols in medical device labeling. In a global marketplace with more than 7,100 spoken languages, manufacturers need to consider the local language and culture when developing medical device product labels. How does one make it possib |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 21 Dec 2022 06:15:14 +0000) |
| Role and Responsibilities of QPPV and LRP |
| This article talks about the role and responsibilities of Qualified Person for Pharmacovigilance (QPPV) and Local Responsible Person (LRP) for compliant market entry of the products. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Fri, 09 Dec 2022 07:29:11 +0000) |
| Key Considerations for Successful Creation and Submission of a 510k eCopy |
| This article talks about the key considerations for successful creation and submission of a 510(k) eCopy. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Fri, 09 Dec 2022 07:28:42 +0000) |
| Key Points to Consider for IVD Self-certification under the EU IVDR |
| This article talks about the key points to consider for device manufacturers for IVD self-certification under the EU IVDR regulations. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Fri, 09 Dec 2022 07:28:08 +0000) |
| USFDA's Step- by- Step Process for Obtaining 510k Clearance for Medical Device |
| This article talks about the USFDA's step- by- step process for obtaining 510(k) clearance for medical device. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Fri, 09 Dec 2022 07:27:41 +0000) |
| USFDA's guidance on cross-labeling anti-cancer drugs for combination therapy |
| This article talks about the USFDA's guidance on cross-labeling anti-cancer drugs for combination therapy |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Fri, 09 Dec 2022 07:26:54 +0000) |
| US FDA Released Draft Guidance on Content and Format of Labeling for Non-prescription Drugs |
| This article talks about the US FDA released draft guidance on content and format of labeling for non-prescription drugs to enhance the labeling consistency. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Fri, 09 Dec 2022 07:26:20 +0000) |
| US FDA Released Labeling Draft Guidance on Dose Banding |
| This article talks about the US FDA released labeling draft guidance on dose banding. In July 2022, the United States Food and Drug Administration (US FDA) issued draft guidance titled āHuman Prescription Drug and Biological Products - Labeling for Dosing Based on Weight or Body Surface Area for R |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Fri, 09 Dec 2022 07:25:23 +0000) |
| Considerations for Adoption and Region Wise Implementation Dates of eCTD 4.0 |
| This article talks about the considerations for adoption and region wise implementation dates of eCTD 4.0 |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Fri, 09 Dec 2022 07:24:03 +0000) |
| Managing Regulatory Intelligence RI in Medical Devices |
| This article talks about the managing regulatory intelligence (RI) in medical devices to ensure device performance and safety. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Nov 2022 12:45:31 +0000) |
| Highlights of the Self-Testing Provision for Medical Devices in China |
| With the enactment of NMPAās Regulations on the Supervision and Administration of Medical Devices - Order 739 in 2021, the medical device registration process in China has undergone substantial changes. The NMPA has implemented several process-related changes to streamline and improve the device r |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Nov 2022 12:44:58 +0000) |
| Importance of GPP3 Guidelines |
| The Committee on Publication Ethics (COPE) was established in 1997 to address research and publishing ethics violations. Its goal was to identify workable solutions to the problems and create best practices. It is a non-profit organization that offers a discussion forum and guidance to scientific ed |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Nov 2022 12:44:22 +0000) |
| Steps to Stop Counterfeit Drugs and Enhance Traceability through Web3 and NFTs |
| As the world is moving towards digital transformation, the introduction of various tools is empowering many industries, including Pharmaceuticals and Life Sciences. In fact, the serialization and traceability of items can be improved even further as the world transitions to a digital economy. Curren |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Nov 2022 12:43:49 +0000) |
| ANVISAās Updated Resolution for Brazilian Good Manufacturing Practices |
| This article talks about the ANVISAās updated resolution for granting or renewing the Brazilian Good Manufacturing Practice (BGMP) certification for medical devices. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Nov 2022 12:38:14 +0000) |
| DMA Revises Submission Deadline for Marketing Authorization MA and Clinical Trial Applications |
| This article talks about the DMA's (Danish Medicines Agency) Revised 2022 submission deadline for Marketing Authorization (MA) and clinical trial applications. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Nov 2022 12:37:42 +0000) |
| Differences between FMEA and ISO 14971 Standards for Medical Devices |
| Risk management is a critical activity across all phases of the medical device lifecycle as it directly affects the safety and well-being of patients. Risks are unavoidable; however, they can be curtailed if companies are aware of impending hazards and follow effective risk management procedures |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Nov 2022 12:35:58 +0000) |
| Mexico's COFEPRIS New Requirements for Online Medical Device Submissions |
| This article talks about the Mexico's COFEPRIS announcement on new regulatory requirements for online medical device submissions |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Nov 2022 12:34:46 +0000) |
| eDMS Platform for Successful Regulatory Operations - Freyr rDMS |
| This article talks about the Freyr rDMS, an electronic document management system(eDMS) and its ideal feautures for successful global regulatory operations. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Nov 2022 12:34:03 +0000) |
| Packaging Security for Brand Protection in the Emerging Markets |
| This article talks about the 360 degree packaging security for brand protection in the emerging markets of the pharmaceutical industry to ensure anti-counterfeiting |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 01 Nov 2022 13:26:07 +0000) |
| CGT exclusivity for an Incentivized Pathway to ANDA Submission |
| Competitive generics are known to be a boon as they pave the way to a lucrative market, provided drug manufacturers can decode the challenging and complicated drug development. Although drug development technologies are constantly evolving, we are yet to comprehend the outcomes of Competitive Generi |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 01 Nov 2022 13:25:38 +0000) |
| Adoption of Artificial IntelligenceAI in Medical Writing |
| "The pharmaceutical and Life Sciences sectors have seen a steady increase in the need for Medical Writing. Patents have been expiring, Regulatory standards have changed quickly, and spending on research and development has been rising constantly. Because of this, the necessity to continuously adapt, |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 01 Nov 2022 05:22:26 +0000) |
| Top 10 FAQs about Korean License Holder KLH |
| Top 10 FAQs about Korean License Holder (KLH)
This article talks about the top 10 Frequently Asked Questions (FAQs) about Korean License Holder (KLH) for MFDS device registration.
FAQs, South Korea, Korean License Holder, KLH, Regulatory Affairs, Medical Devices, MFDS, Device registration |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 01 Nov 2022 05:20:54 +0000) |
| Top FAQs about Medical Device Single Audit Program MDSAP |
| Top FAQs about Medical Device Single Audit Program (MDSAP)
This article talks about the top FAQs about Medical Device Single Audit Program (MDSAP) for auditing and monitoring the QMS of medical device manufacturers.
ANVISA, FDA, Medical Devices, Medical Device Single Audit Program, MDSAP, Auditing |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 01 Nov 2022 05:20:19 +0000) |
| Classification of Medical Devices under EU MDR |
| This article talks about the classification of medical devices under EU MDR and EU IVDR. Medical Devices, Competent Authority, EU MDR, EU IVDR, digital health, In Vitro Diagnostic devices, Product Classification
Classification of Medical Devices under EU MDR |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 26 Oct 2022 05:24:51 +0000) |
| Significance of Pharmacogenomic Biomarkers in Biological Drug Labeling as per USFDA |
| This article talks about the USFDA perspective on significance of pharmacogenomic biomarkers in biological drug labeling. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 26 Oct 2022 05:24:21 +0000) |
| NMPA's Regulatory Landscape for Digital Health Technologies in China |
| This article talks about the NMPA released regulatory landscape for digital health technologies in China. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Fri, 21 Oct 2022 14:31:07 +0000) |
| Determination of F-value for child-resistant packaging |
| This article talks about the determination of the F-value to make the child-resistant packaging in Pharmaceuticals for compliant market entry. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Fri, 21 Oct 2022 14:29:49 +0000) |
| Importance of a Technical Writer for Medical Device Manufacturers |
| This article talks about the importance of a technical writer for medical device manufacturers for compliant documentation. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Fri, 21 Oct 2022 14:27:28 +0000) |
| ANVISA Approves Key Drugs and Vaccines to Fight Against Monkeypox |
| This article talks about the ANVISA approved key drugs and vaccines to fight against Monkeypox in Brazil.Monkeypox, Monkeypox virus, Drugs and Vaccines, Tecovirimat, Jynneos Vaccine, Imvanex Vaccine, ANVISA, Prescription Drugs, Regulatory Medical Writing, Infection Control |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 19 Oct 2022 08:49:27 +0000) |
| Transition from eCTD version 3.2.2 to eCTD version 4.0 |
| This article talks about the transition from eCTD version 3.2.2 to eCTD version 4.0 and its benefits for compliant electronic submissions.
eCTD, eCTD tool, Freyr SUBMIT PRO, USFDA, eCTD v4.0, eCTD v3.2.2, electronic submissions |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 19 Oct 2022 08:47:00 +0000) |
| Doās and Donāts of Class I Self-certification under the EU MDR |
| This article talks about the Doās and Donāts of Class I Self-certification under the EU MDR.
self-certification, class I devices, Medical Devices, Regulatory Affairs, EU MDR, digital health, MDD, Device Classification, European Union |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 19 Oct 2022 08:46:01 +0000) |
| Dos and Donāts for CE Certification of Class I Sterile Medical Devices |
| This article talks about the dos and donāts for CE certification of Class I sterile medical devices in the European Union. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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