Updated on 10 September 2026
Regulatory Affairs & Market Authorization Support
Business Development & Marketing Senior Officer at Owlpharma - Consulting, Lda.
Lisboa, Portugal
About
Owlpharma's Regulatory Affairs Department provides full-spectrum regulatory support to pharmaceutical and healthcare companies, guiding products through every stage of the regulatory lifecycle. From early regulatory strategy and dossier preparation to marketing authorization submissions and post-approval maintenance, our experts help organizations navigate complex regulatory requirements efficiently and compliantly.
Our services include:
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Development Phase Support
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Review and preparation of Marketing Authorisation (MA) dossiers
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Regulatory strategy development for MA approval
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Conversion of dossiers to eCTD format
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Pre-Marketing Authorisation Activities
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Preparation, submission, and management of MA applications in EU and non-EU markets
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Local representation as Marketing Authorisation Holder (MAH)
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Pricing and reimbursement applications
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Regulatory support for product launch and commercialization
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MA dossier audits
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Post-Marketing Authorisation Support
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Preparation, submission, and management of variations and renewals
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Drug information management through the EudraVigilance platform (XEVMPD)
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Regulatory review and support for advertising and promotional activities
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Type
- Consulting
Applies to
- Pharmaceutical industry
Organisation
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Service
Regulatory Strategy for Faster Market Access
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- Cosmetic industry
- Health innovation
carmen M. Lerga
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Expertise
- Healthcare
- Biotech, Pharma and Cosmetics
Raquel López Moreno
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Service
Quality Assurance & GxP Compliance Services
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- Health innovation
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Adriana Alves
Business Development & Marketing Senior Officer at Owlpharma - Consulting, Lda.
Lisboa, Portugal