The Origin of the OSHA HazCom Standard The U.S. Occupational Safety and Health Administration Hazard Communication Standard (OSHA HCS or HazCom Standard) was first adopted in 1983. The HCS requires chemical manufacturers and importers to provide information about the identities and hazards of the substances and mixtures they produce and distribute, and to communicate that […]
OSHA Proposed HazCom Implementation of GHS Revision 7 Read More »
The Origin of WHMIS Canada’s Occupational Health and Safety Act ensures workers’ right to know about health and safety hazards in the workplace. Because of this requirement, Canada developed a national hazard communication standard known as the Workplace Hazardous Materials Information System (WHMIS), which allows all Canadian workers to access information about the hazardous substances
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Making an eCTD-compliant submission to the FDA requires complex coordination of stakeholders and a detailed culmination of information. Translating years of product information must be done in a way that provides the necessary information to FDA and frame it into the correct formatting for review; a task often requiring seasoned support. Avoid technical issues preventing or
FDA Submissions Using eCTD Formatting: Structural Overview & Common Hurdles Read More »
Suspensions, whilst not as common as tablets and capsules, are a very useful dosage form in several therapeutic areas. Typically, these active pharmaceutical ingredients (API) are associated with pediatric use, suspensions also have a valuable role to play in geriatric medicine as many elderly patients have trouble swallowing solid dosage forms. Often, suspensions are thought
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Lipophilic compounds have a notorious reputation for being challenging to formulate, but, with the help of today’s technology and excipients, we’re here to disprove this notion. Be it poor aqueous solubility, variable absorption, or instability, drug developers hoping to achieve acceptable lipophilic drug products have been plagued for decades with consistent challenges. Break away from
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Relocating your laboratory can be a strenuous endeavor if taken on alone. Your lab is a central asset to your program’s success and must be treated accordingly. Before entrusting this important task to your chosen partner, take the time to understand the process ahead and leave no box unchecked. As soon as you know your
Relocating Your Laboratory – Step by Step Read More »