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OWLPHARMA Consulting
Products
Clinical Research *
Clinical Reporting
Product Development
Real World Data Research
Study Operations & Management
Trial Design & Planning
Commercialization *
Brand Planning & Activation
Customer Engagement
Finance & Investment *
Financial Services
Investment Banking
Market Access & Policy *
Global Market Access
Government Policy
Medical Affairs *
Defining the Value of Medical Affairs
Evidence Generation
Scientific Communications Development
Strategic Communications Planning
Strategic Stakeholder Engagement
Pharmacovigilance *
Risk Management
Safety Systems
Quality & Mfg *
Facilities & Equipment
Production & Supply Chain
Quality Management
Testing & Release
Regulatory *
Compliance
Labeling & Promotions
Maintenance & Renewals
Transparency & Disclosure
Technology & Operations *
Automation & Efficiency
Data & Analytics
Digital Health Solutions
Early Development
Informatics Infrastructure
Operations
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Projects
Clinical Research *
Clinical Reporting
Product Development
Real World Data Research
Study Operations & Management
Trial Design & Planning
Commercialization *
Brand Planning & Activation
Customer Engagement
Finance & Investment *
Financial Services
Investment Banking
Market Access & Policy *
Global Market Access
Government Policy
Medical Affairs *
Defining the Value of Medical Affairs
Evidence Generation
Scientific Communications Development
Strategic Communications Planning
Strategic Stakeholder Engagement
Pharmacovigilance *
Risk Management
Safety Systems
Quality & Mfg *
Facilities & Equipment
Production & Supply Chain
Quality Management
Testing & Release
Regulatory *
Compliance
Labeling & Promotions
Maintenance & Renewals
Transparency & Disclosure
Technology & Operations *
Automation & Efficiency
Data & Analytics
Digital Health Solutions
Early Development
Informatics Infrastructure
Operations
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About
Overview
Full regulatory support: from initial guidance to dossier preparation/build-up, MA submission and post-MA dossier management.
Development
- Review and preparation of MA dossiers;
- Definition of regulatory strategies for MA approval;
- Conversion to eCTD format.
Pre-MA
- Preparation, submission and management of MA applications (EU and non-EU);
- Local representative as MAHs;
- Price and reimbursement applications;
- Regulatory support on the launch and marketing of medicines.
Post-MA
- Preparation, submission and management of variation and renewal applications of MA (EU and non-EU);
- Drug information management on Eudravigilance Platform (XEVMPD);
- Advertising regulatory support.
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