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Active Pharmaceutical Ingredients FInished Dosage Forms

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

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

Opex

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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