Project Management

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Is it required that quality, regulatory and Project management go in tandem for Pharmaceutical delivery

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I often see that regulatory requirements define the project objectives, its not other way around. So would like your views on the same 
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Kiron Bondale Retired | Mentor| Retired Welland, Ontario, Canada
It really depends on what the purpose of the project is. Some projects are launched to meet regulatory compliance needs in which case those requirements would be the primary ones whereas in other projects a different driver such as market share or revenue by researching, developing and successfully launching a new drug might have functional requirements with regulatory requirements being part of the quality obligations.

This is also affected by the culture of the company and the perspective of the project's key stakeholders as to what is most important to them.

Kiron
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Sergio Luis Conte Helping to create solutions for everyone| Worldwide based Organizations Buenos Aires, Argentina
We are creating solutions, where solution is "the thing" to be created plus "the way" to create it. You can call them product and project. Product requirements define project requirements. That´s all you have to take into account as an answer for your question. Usually, business analyst works with focus on product while project manager works with focus in project. Quality is part of the non-functional requirements of the product.
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Rami Kaibni
Community Champion
Senior Projects Manager | Field & Marten Associates New Westminster, British Columbia, Canada
Raghavendra, in most cases, regulatory requirements act as a constraint to projects and they should comply with them be it building codes, governmental or environmental regulations and others.
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Md. Golam Rob Talukdar
Community Champion
Project Manager| AWR Development (BD) Ltd. Cox's Bazer , Bangladesh
Hi Raghavendra,

Yes, it's important for Quality, Regulatory, and Project Management teams in pharma to work together.

Regulatory requirements often guide project goals to ensure compliance and safety.

When these teams cooperate, it leads to smoother processes and better results.

Thank you,

Golam

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