FAQ

What types of companies do you typically work with?

I typically work with startups at the proof-of-concept level or those with unclear regulatory strategies, helping them clarify their regulatory objectives and build a roadmap for success.

How do you help with early-stage regulatory strategy?

I provide guidance for early-stage companies, focusing on regulatory strategy from pre-IND meetings up to Phase 1 and beyond, ensuring compliance and a clear path forward through the regulatory process.

Do you offer monthly or long-term contracts?

I offer contracts ranging from three to six months, depending on the complexity of the project and the regulatory needs of the company.

What is the preferred frequency for meetings?

I prefer weekly meetings, especially during the early stages of the project, to maintain momentum, ensure progress, and address any issues promptly.

What is the process for starting a project with you?

The process begins with a project presentation, where objectives and key deliverables are outlined, followed by the development of a tailored regulatory strategy.

What kind of support do you provide after market approval?

After market approval, I provide post-marketing surveillance, including ongoing compliance monitoring and actions if necessary. I also help identify competent professionals to manage the ongoing regulatory needs of your product.

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Gautam's broad network features distinguished business specialists with substantial IPO experience, notably achieving the rare feat of executing two IPOs in one month, including a successful listing on NASDAQ, readily available for consultation via phone or email.

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