Spharm-inc.com

Canada's Regulatory Experts for Drug & Health Products

WEBCanada's Regulatory Experts for Drug & Health Products. Pharmaceutical, biotechnology, natural health product and medical device companies from around the world count on …

Actived: 3 days ago

URL: https://spharm-inc.com/

New Drug Submission Process in Canada

WEBNDS stands for “New Drug Submission” in Canada, other acronyms would apply outside Canada. It is the regulatory process required by Health Canada that pharmaceutical …

Category: Health Go Health

How to Determine your Regulatory Affairs Needs

WEBHiring at the start to define needs and formulate a strategic regulatory plan produces three significant advantages: Ensure the research is relevant and that it will address a medical …

Category: Medical Go Health

The Drug Review and Approval Process in Canada – An eGuide

WEBPhase 2 – The Effectiveness phase. In this phase, the drug is given to a larger group of individuals with the pathology to be treated (usually several hundred). The purpose is to …

Category: Health Go Health

How does Canada’s Application process compare to USA and EU

WEBThe review period is always 30 days, whereas in some European countries the review period can be as long as 60 days or more, and in the US it can vary. Due to the standard …

Category: Health Go Health

Clinical Trial Site Information Forms – a Health Canada update

WEBWe recently communicated with our clients and partners about the recent changes Health Canada has made regarding the electronic submission of Clinical Trial Site Information …

Category: Health Go Health

Clinical Trial Applications

WEBThe Clinical Trial Application Process with SPharm – from complex to streamlined. As Clinical Trial Application & Regulatory Affairs experts, SPharm is ideally suited to handle …

Category: Health Go Health

How long does it take a drug product to be approved in Canada

WEBThe Canadian review timeline for a New Drug Submission (NDS) is competitive. A standard review consists of a maximum of 10 days eCTD validation, followed by 45 days …

Category: Health Go Health

Overcoming Obstacles in the Drug Approval Process in Canada

WEBSusanne Picard is the founder & president of SPharm, one of Canada’s leading strategic Drug Development and Regulatory Advisory firms. A highly regarded expert, Susanne …

Category: Health Go Health

Notice of Compliance with Conditions versus Priority Review

WEBThe total review timeline is reduced from 355 days to 215 days. On the other hand, the Notice of Compliance with condition (NOC/c) applies to drugs with promising evidence of …

Category: Health Go Health

Myths of clinical trial and drug approval process in Canada

WEBMyth #5: Health Canada’s process for approving new drugs is excessively slow. Reality: Health Canada have established submission review targets that are respected. …

Category: Health Go Health

Drug Review & Approval Process in Canada – An Infographic

WEBAN INFOGRAPHIC. What follows is a graphical representation, an Infographic, of the eGuide we published titled “ The Drug Review Approval Process in Canada – An eGuide …

Category: Health Go Health

Are separate Clinical Trial Applications required

WEBDoes Health Canada require separate Clinical Trial Applications for each protocol is a question often asked. Presently, drug developers may submit more than one protocol …

Category: Health Go Health

NEW DRUG SUBMISSION PROCESS HEALTH CANADA

WEBApproval would be granted to a manufacturer to market and sell that drug in Canada with the condition that the manufacturer execute additional studies to confirm the drug’s …

Category: Health Go Health

Drug Regulatory Training & Consulting for Canada

WEBLearn more about SPharm's Drug and Health Product Regulatory Training services for biotechs and pharmaceutical companies working with Health Canada.

Category: Health Go Health

Health Canada issues a new guidance GUI-0064

WEBLinkedIn Email. 16 November 2016 Health Canada announces the issuance of a new Guidance GUI-0064: How Health Canada inspects medical device establishments. …

Category: Medical Go Health

eGUIDE The Review Approval Process In Canada

WEBeGUIDE The Drug Review & Approval Process In Canada Canada’s Drug Regulatory Experts

Category: Health Go Health

Are Sponsors required to have a legal representative reside in …

WEBDoes Health Canada require Sponsors to have a legal representative reside in Canada? DOES HEALTH CANADA REQUIRE SPONSORS TO HAVE A LEGAL …

Category: Health Go Health

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