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- Quality & Compliance Services | Acknown Pharma
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Business Growth
Business Profitability
- Capex
- Opex
Pharmaceutical Sourcing
- Raw Materials & API Sourcing
- Finished Dosage Form
Quality & Compliance
- Quality & Compliance Services | Acknown Pharma
- Regulatory
IP & Legal
- IP Services
- Legal Services

Finished Dosage Form

Business Growth

New Market Entry Existing Market Optimisation New Product Existing Product

Business Profitability

Pharmaceutical Sourcing

Raw material and API Sourcing Finished Dosage form sourcing

IP & Legal Services

Intellectual Property (IP) Strategy Freedom-to-Operate (FTO) Analysis:Trademark Search and Filing NDA/CDA Templates Patent Drafting Design-Around & Non-Infringing Patent Strategies Contract Drafting In-Licensing, Out-Licensing, Distribution, & Acquisition Agreements Contract Review from Commercial and Legal Perspectives

Quality & Compliance

GMP Audits (API & Finished Dosage Form)Triggering Plant GMP Compliance Qualified Person (QP) Services for EU Release and Testing Services

Regulatory

Regulatory Dossier Compilation (CTD, eCTD, ACTD)Dossier Gap Analysis & Compliance Due Diligence Filing Strategy Advisory & Regulatory Query Management Pharmacovigilance & Drug Safety Monitoring

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