Gayatri Gurjar

Regulatory Project Manager (BLA Regulatory LLC), Quality & Regulatory Affairs (Medical Devices, Drugs & Biologics), Regulatory submissions, ISO 13485 QMS, Risk management, MDSAP & CE marking

Role: Regulatory Project Manager at Bla Regulatory
Location: Pune, MH, IN
LinkedIn followers: 500 followers

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About Gayatri Gurjar

Recent work experience involves: o Spearheading regulatory submissions to CDSCO…

Experience

Regulatory Project Manager
Bla Regulatory
Jan 2025 — Present

Education

Pune University-National chemical laboratory
Doctor of Philosophy - PhD
2003 — 2010
Goa University
M.Sc
2000 — 2002

Contact information

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Work email
•••••@bla-regulatory.com
Personal email
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Current company

Bla Regulatory

Biotechnology Research · 9 employees · Gaithersburg, Maryland, United States

The R&D process of bringing a new drug to the market can take many years. It is therefore essential that the process is managed effectively from beginning to end to meet the regulatory requirements and permit a favorable evaluation of efficacy and safety in the shortest possible time. BLA Regulatory, as your Trusted Partner in Regulatory Affairs, will guide you through every step of the regulatory process by creating a tailored end-to-end approach depending on your product and your company’s needs. With a combined experience of more than 130 years, the team brings in collective knowledge from major biopharmaceutical companies, CROs, and the FDA. Our qualified expertise expands across CMC, nonclinical, clinical, statistics, scientific writing, and project management. The team has extensive experience in the complete drug development cycle with records of approvals for innovative drugs across therapeutic areas. Our approach emphasizes building up marketing applications from a solid IND strategy by providing expertise, regulatory intelligence, and translating regulatory requirements into practical workable plans throughout the product development cycle. As your partner and extension of your team, we will leverage our strengths and experience to provide oversight of the full product life cycle and ensure compliance of the product development and marketing program through the services we provide.

bla-regulatory.com

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About Gayatri Gurjar

Experience

Regulatory Project Manager

Education

Pune University-National chemical laboratory

Goa University

Find verified contacts for anyone on LinkedIn