Expert Submissions

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

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Thais Almeida

Regulatory Affairs Manager

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Martha Lee

Senior Regulatory Affairs

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Sarita Adlakha

Pharma Regulatory Consultant

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Email (Verified)
***@terumobct.com

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Mobile Number
(XXX) XXX-XXXX

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Location
Hastings-on-Hudson,New York,10706,United States

Company
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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Expert Submissions currently works for Regulatory Affairs Consultant.

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Expert Submissions's email address is ***@terumobct.com. To view Expert Submissions's full email address, please signup to ConnectPlex.

Expert Submissions works in the Pharmaceuticals industry.

Expert Submissions's colleagues at Regulatory Affairs Consultant are Thais Almeida, Martha Lee, Luana Staiger, Michael Burdick, Sarita Adlakha and others.

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