Blog - Royed Training

A case based understanding in co-development deal

Posted on21 Feb 2024

Tagsbiopharma business, Biopharma business development, co-development deal, Pharma Business

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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 partners together jointly...

Case analysis: 483 observations – Data Integrity issues in a pharmaceutical finished dosage formulation plant

Posted on21 Feb 2024

Tags483 observation, warning letter

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The US Food and Drug Administration has pointed out data integrity lapses at XYZ Pharma’s finished dosages plant at <Location>. The FDA issued Form 483...

What is the difference between 505j application, 505b1 NDA & 505b2 NDA?

Posted on21 Feb 2024

Tags505b1, 505b2, 505j, fist to file generics

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In this topic we will be discussing about 505j, 505b1 and 505b2 application and differences between all 3 applications. The 505(j), 505(b)(1), and 505(b)(2) applications...

What is an audit trail?

Posted on21 Feb 2024

Tagsaudit trail

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An audit trail is a chronological record of events or actions that have occurred within a system or process. Audit trail means a secure, computer-generated,...

What are the difference between FDA 483 and Warning Letter?

Posted on21 Feb 2024

Tags483 observation, regulatory affairs, warning letter

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483 observation or FDA 483 and warning letter seems to be same, nut there is difference between the FDA form 483 and Warning Letter. Let...

What is Biologic License Application (BLA)?

Posted on21 Feb 2024

TagsBiologic License Application, biologic regulatory affairs, BLA

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A Biologic License Application (BLA) is a submission to the USFDA requesting permission to market and distribute a biologic product. Biologic products are therapeutic agents...

What is difference between Form 483 and Establishment Investigation Report ?

Posted on21 Feb 2024

Tags483 observation, regulatory affairs, warning letter

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Form 483 and an Establishment Investigation Report (EIR) are both documents used by regulatory authorities, particularly the U.S. Food and Drug Administration (FDA), but they...

What is Design of experiments (DoE) approach?

Posted on21 Feb 2024

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Design of experiments (DoE) is a systematic approach aiming to maximize information content from an experimental study, while keeping the number of experiments low. During...

What is Quality by Design (QbD)?

Posted on21 Feb 2024

Tagsproduction management, QbD, regulatory affairs

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The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process...

Indication splitting in biopharma licensing

Posted on21 Feb 2024

Tagsbiopharma business, Biopharma business development, indication splitting, Pharma Business, Pharma Business Development

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While licensing in bio pharmaceutical business, if licenses are issued to different partners based on indications or disease and therapy, then this concepts is known...

What are the difference between regulatory affairs and pharmacovigilance working?

Posted on21 Feb 2024

Tagspharmacovigilance, regulatory affairs, regulatory pharmacovigilance

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Pharmacovigilance professionals deals with the adverse effects, and regulatory professionals work on registration and regulation of drug. Pharmacovigilance professionals are focused on the science of...

What are the key auditing standards in pharmaceutical industry?

Posted on05 Feb 2024

Tagsgmp audit, pharmaceutical audit

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A pharmaceutical audit is a systematic, independent examination of a pharmaceutical company’s operations and processes to ensure compliance with Good Manufacturing Practices (GMP), regulatory guidelines,...