What are the difference between Wholesaler and Specialty Pharmacy?
Posted on21 Feb 2024
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There are clear cut difference between the two terms. The wholesalers are the first purchaser of the drug, directly from manufacturer. Specialty... Read More
A case based understanding in co-development deal
Posted on21 Feb 2024
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In a Co-Development Agreement the intellectual property is typically licensed by the licensor to the alliance partner, and as well, the two... Read More
Case analysis: 483 observations – Data Integrity issues in a pharmaceutical finished dosage formulation plant
The US Food and Drug Administration has pointed out data integrity lapses at XYZ Pharma’s finished dosages plant at <Location>. The FDA... Read More
What is difference between Form 483 and Establishment Investigation Report ?
Form 483 and an Establishment Investigation Report (EIR) are both documents used by regulatory authorities, particularly the U.S. Food and Drug Administration... Read More
What is Quality by Design (QbD)?
The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process... Read More
Indication splitting in biopharma licensing
While licensing in bio pharmaceutical business, if licenses are issued to different partners based on indications or disease and therapy, then this... Read More
What is a CDMO?
A Contract Development and Manufacturing Organization (CDMO) serves clients various services from drug development to contract manufacturing. Services offered by CMOs include, but... Read More
What is form 356h?
The FDA Form 356h is a specific document used in the United States by pharmaceutical companies and other entities involved in the... Read More
Career in CMC Writing
A career in CMC (Chemistry, Manufacturing and Control) writing can be both rewarding and intellectually stimulating. It involves the development and preparation... Read More
Differences between the Laboratory Pilot and Commercial Scale
Posted on17 Oct 2023
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There are three different types of scale of operation in pharmaceutical manufacturing. Let us explore the differences between each of these scales.... Read More