Profile Details

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USD 50 /hr

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☆☆☆☆☆

Hire Dr. Codette P.

India

USD 50 /hr

One stop solution for end to end Life Sciences global Regulatory support.

Profile Summary

Codette Pharma Regulatory Analytics Pvt Ltd provides top-level global regulatory and clinical support to Life Science companies. We are experts in electronic common technical document (eCTD) submissions to global health authorities, Regulatory writing and Biostatistical support. We have experienced staff of industry-trained professionals to manage all aspects of global and Indian Regulatory support. Our experts can guide your organization through submissions, perform due diligence and step in to support your experts during project load peaks. Our services include . eCTD Submissions, . Global Regulatory Publishing Services, . Clinical Regulatory Lifecycle Management, . Indian Regulatory Services, . Biostatistical operations, . Medical Writing, . Clinical Data Management, . Biowaiver Designing, . Statistical Modelling and Population-pharmacokinetics, . In-Vitro Bioequivalence, . Subsequent New Drug Application, . Import License , . Medical Device Application, . New Drug Approval, . Contract Manufacturing License, . Wholesale License, . Loan License, . Variation Submission, . Regulatory Content Analysis, . Subject Expert Committee Meetings

Subject Matter Expertise

• ★ European Medical Device Regulation (MDR)
• ★ Regulatory Writing
• ☆ Biostatistics
• ☆ Data Science
• ☆ Data Processing
• ☆ Data Manipulation
• ☆ Clinical Study Reports

Services

• Writing
• Research
• Consulting
• Data & AI

Writing Technical Writing

Research Secondary Data Collection

Consulting Scientific and Technical Consulting

Data & AI Statistical Analysis

Work Experience

Director

Codette Pharma Regulatory Analytics Pvt Ltd

June 2020 - Present

Education

PhD

Medical University of Graz

October 2014 - September 2019

Certifications

• Certification details not provided.