Michael Burdick

Consultant at Regulatory Affairs Consultant - Los Angeles, California, United States

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Regulatory Affairs Manager

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Senior Regulatory Affairs

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Luana Staiger

Independent

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Sarita Adlakha

Pharma Regulatory Consultant

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Los Altos,California,United States
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Regulatory Affairs Consultant
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Regulatory Affairs Consultant

Los Angeles, California, United States • 12 Employees
Pharmaceuticals

I provide regulatory strategic advice for investigational drug development from early stage (IND enabling) through to NDA filings. I also provide medical and technical writing for clinical, nonclinical, and CMC sections of applications and other correspondences with the FDA.List of services:- IND, ANDA and NDA/BLA administrative information- Clinical summaries (2.5, 2.7) and Clinical Study Reports- Nonclinical summaries (2.4, 2.6)- Quality Overall Summary (2.3)- Expedited programs (Fast Track, Breakthrough Therapy, RMAT, and Priority Review designations)- Pediatric programs (Pediatric Study Plan, Paediatric Investigation Plan)- Rare disease programs (Orphan designation)- Drug Master File annual report- IND Annual Report/Development Safety Update Report- FDA meeting requests- Safety reports- Labelling (package insert/SPL, container labels)- Proprietary names- Gap analyses- Regulatory intelligenceFor inquiries, please send an email to robert.cormack@outlook.com.

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