Expert Support for Successful NDA Submissions

The Griesser Group consists of professionals with expertise in Statistics, and Statistical Programming, all bringing extensive experience in New Drug Applications (NDAs) across a broad range of therapeutic areas. Our team ensures precise, reliable support to help clients successfully navigate complex regulatory processes.

Industry Expertise and Proven Success

Experience

With over 100 years of combined experience in the pharmaceutical and biotech industries, our team excels across both the sponsor and CRO sectors, delivering tailored, high-quality solutions for the pharmaceutical development process.

Success

Our extensive NDA experience is pivotal to the success of sponsor companies, guiding them through the regulatory process to ensure the successful development and submission of pharmaceutical products.

Results

Having contributed to the successful filing of over 25 NDAs, our team is adept at navigating complex regulatory landscapes and driving impactful results that bring products to market.

Quality

We specialize in integrating data across homogeneous studies, facilitating the creation of precise Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS) reports that adhere to the highest industry standards.

CDISC Expertise

As a CDISC Gold Member, we've played an integral role in developing and implementing CDISC standards. Our leadership and contributions to teams such as ADaM, SDS, and Training reflect our ongoing commitment to advancing global data standards.

Discover Our Expertise

We are dedicated to delivering high-quality statistical and clinical programming services. Explore how we can assist your projects today.

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