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02/06/2023

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https://ipharmed.com/premarket-notification-510k-submissions-for-ultrasonic-diathermy-devices-guidance-for-industry-and-food-and-drug-administration-staff/

This guidance document provides recommendations for 510(k) submissions for ultrasonic diathermy devices, also known as physiotherapy devices. Ultrasonic diathermy devices are devices under section 201(h) of the Federal Food, Drug and Cosmetic Act (the FD&C Act). This guidance includes recommendation...

02/06/2023

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Email: bd@ipharmed.com | Call: +91 81970 38719 | www.ipharmed.com

14/05/2023

Happy Mother's Day..

13/05/2023

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https://ipharmed.com/assemblers-guide-to-diagnostic-x-ray-equipment-guidance-for-industry-and-food-and-drug-administration-staff/

The Center for Devices and Radiological Health (CDRH) is charged with the responsibility for enforcing regulations created under the Radiation Control for Health and Safety Act of 1968 (Public Law 90-602) (the Act). The Act was later moved to the Federal Food, Drug, and Cosmetic Act (FD&C Act) with....

29/04/2023

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https://ipharmed.com/product-specific-guidance-meetings-between-fda-and-anda-applicants-under-gdufa-guidance-for-industry/

This guidance provides recommendations to industry on product-specific guidance (PSG) meetings between FDA and a prospective applicant preparing to submit to FDA or an applicant that has submitted to FDA an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug and Co...

28/04/2023

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Email: bd@ipharmed.com | Call: +91 81970 38719 | www.ipharmed.com

23/04/2023

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https://ipharmed.com/medical-x-ray-imaging-devices-conformance-with-iec-standards-guidance-for-industry-and-food-and-drug-administration-staff/

This guidance describes FDA’s policy regarding the regulation of medical x-ray imaging equipment that is subject to the Federal Food, Drug & Cosmetic Act (FD&C Act) and FDA’s regulations that apply to medical devices and electronic products. In this guidance, FDA is seeking to harmonize performa...

23/04/2023

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08/04/2023

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https://ipharmed.com/q13-continuous-manufacturing-of-drug-substances-and-drug-products-guidance-for-industry-2/

INTRODUCTION (1)2 A. Objective (1.1) This guidance describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing International Council for Harmonization (ICH) Quality guidances, this....

28/03/2023

Check out our Latest Blog Article

https://ipharmed.com/neovascular-age-related-macular-degeneration-developing-drugs-for-treatment-guidance-for-industry/

This guidance is intended to provide recommendations to sponsors regarding eligibility criteria, trial design considerations, and efficacy endpoints to enhance clinical trial data quality and to foster greater efficiency in development programs for drugs for the treatment of neovascular age-related....

28/03/2023

IPHARMED Provides best Regulatory Solution for pharma and medical device industries

Email: bd@ipharmed.com | Call: +91 81970 38719 | www.ipharmed.com

27/03/2023

Check out our Latest Blog Article

https://ipharmed.com/q13-continuous-manufacturing-of-drug-substances-and-drug-products-guidance-for-industry/

Q13 Continuous Manufacturing of Drug Substances and Drug Products Guidance for Industry March 23, 2023March 23, 2023 by ipharmedservices INTRODUCTION (1)2 A. Objective (1.1) This guidance describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle...