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 manufacturing and distribution... Read More
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Job descriptions of CMC Writer
CMC Writer’s primary responsibility is to ensures smooth progress of regulatory CMC submissions to health authorities. They involves in regulatory CMC submissions – applying intelligence... Read More
Self Assessment Test on CMC Writing
Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory documentation process. They Support regulatory CMC writing activities including... 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 of documents that... 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. Laboratory scale means... Read More
What is the meaning of scale up in pharma industry?
A Scale-up is an important concept in pharmaceutical and biopharmaceutical manufacturing industry. In the pharma industry, scale up refers to the process of increasing the... Read More
What is difference between 351(a) vs. 351(k) pathway?
the terms 351(a) pathway and 351(k) pathway are typically associated with the approval of biological products, particularly in the context of the United States Food... Read More
What is difference between co-promotion and co-marketing deal in pharma?
Posted on17 Oct 2023
Tagsbiopharma business, Biopharma business development, comarketing, copromotion, inlicensing, Outlicensing, Pharma Business
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With co-marketing you have the same product, but different brands. With co-promotion, there is only 1 brand, but 2 different sales forces. CO-MARKETING DEAL In... Read More
List of Leading Life Science Consulting companies
Posted on15 Oct 2023
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Life Science consultants can work in large global organizations to specialized mid-small scale life science consulting organizations. Some well-known consulting firms that operate in the... Read More
How to make a career in life science consulting?
Making a career in life science consulting can be a rewarding and intellectually stimulating path, but it requires a combination of education, skills, and networking.... Read More
Significance of Schedule H1 Drugs
Followed by the recent notification by Government of India (GOI) to omit 40 drugs from Schedule H, the drugs are included in the new Schedule... Read More
What is the difference between medical writing and cmc writing?
Medical writing and CMC (Chemistry, Manufacturing, and Controls) writing are two distinct areas within the pharmaceutical and biopharmaceutical industry. They involve different types of documentation... Read More