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Health Canada’s newest regulatory pathway is for products

WebHealth Canada’s ATP pathway. This led to the decision to establish a new Advanced Therapeutic Products (ATP) Pathway. ATP products are defined as health …

Actived: 9 days ago

URL: https://regulatory.axsource.com/health-canadas-newest-regulatory-pathway-is-for-products-that-dont-quite-fit/

What Is Computer System Validation

WebComputer system validation (CSV) is the process of providing a high degree of assurance through documented evidence that a computer system consistently meets …

Category:  Health Go Health

Health Canada, FDA Process Validation Guidance

WebOverall outline of AXSource’s Validation Master Plan (VMP), states how the validation will be conducted, including: AXSource Consulting uses a lifecycle approach to Health/Canada …

Category:  Health Go Health

An update on the new XML Product Monograph (XML PM)

WebBenefits of the eXtensible Markup Language Product Monograph (XML PM): The main objective of XML PM implementation is to better protect the health and safety …

Category:  Health Go Health

SPM & SPL Labeling, US FDA, Health Canada

WebSubmit SPL FDA label. For a quote on SPL labeling services for United States FDA, contact [email protected]. Please consult our website for information on additional regulatory …

Category:  Health Go Health

Tackling diversity in clinical trials

WebThe aim of clinical trials is to provide base evidence on the safety and efficacy of drug products. Collecting disaggregated data on sex, age, and race, will allow Health …

Category:  Health Go Health

Does Computer System Validation Apply To You

WebComputer System Validation has been a regulatory (e.g. FDA, Health Canada) requirement for more than two decades. Nevertheless, companies have problems with its …

Category:  Health Go Health

Health Canada now requires Drug Labelling in XML PM format

WebHealth Canada published a Notice of Intent for transition of labelling content into XML format on April 10, 2019, which stated that the XML PM implementation will be a phased …

Category:  Health Go Health

Pharmaceutical Regulatory Affairs Services in Canada, USFDA

WebTo find out more about how AXSource can help you, please call us at +1 905-854-6059 or email us at [email protected]. AXSource provides pharmaceutical regulatory affairs …

Category:  Health Go Health

Health Canada MDEL renewal for 2022

WebCurrently, Health Canada is not accepting ALRs by mail – you must email your ALR to [email protected]. Fees. Fees are required for the Agency to process …

Category:  Health Go Health

Pharmacovigilance & Risk Management

WebAXSource supports the following pharmacovigilance services: AxSource also offers pre-market services in Clinical Affairs, including review and follow-up of SAEs and clinical …

Category:  Health Go Health

Pharmacovigilance Requirements, Regulations, PV Guidelines

WebREFERENCES. The Importance of Pharmacovigilance – Safety Monitoring of Medicinal Products, WHO, 2002. Good Pharmacovigilance Practices (GVP) Guidelines (GUI …

Category:  Health Go Health

Active Pharmaceutical Ingredient Market, API Registration

WebAn active pharmaceutical ingredient (API) is an active ingredient or raw material used in the fabrication of a pharmaceutical drug dosage form. API quality directly impacts the safety …

Category:  Health Go Health

OTC registration, Food & Dietary Supplement Registration, FDA, …

WebNon-prescription drugs, also called over-the-counter drugs (OTC), are health products that can be bought without a doctor’s prescription and sold directly to consumers. In Canada …

Category:  Health Go Health

eCTD Publishing & Submission Services, FDA, Health Canada

WebElectronic Submission Types. Electronic CTD (eCTD) Services. We fully support the preparation, conversion, and compilation of your documentation for conformance to …

Category:  Health Go Health

Health Canada issues a new Interim Order for COVID products

WebAt the start of the COVID-19 pandemic, Health Canada issued an interim policy to allow the import of products that do not fully meet regulatory requirements, but were comparable, …

Category:  Health Go Health

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