The product you are looking for is not available for licensing? Abheshu will take over the development on your behalf, with a comprehensive management of all project phases if desired.
As an experienced and reliable partner, Abheshu has been successfully supporting its customers in their development projects for many years – from the initial idea to the submission of the final documentation. Out-Licensing of Dossiers for Finished Dosage Forms of Finished Products (Oral solid dosage forms, Semi- solids, Liquids & Injectables). Third-party API & Finished products manufacturing involves outsourcing the production of active pharmaceutical ingredients to specialized companies, offering cost savings, flexibility, and access to expertise. The process typically involves product selection, documentation, artwork/packaging design, production and quality control, logistics/distribution, and post-production support.
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Product Selection and Formulation
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Finding the Right Third-Party Manufacturer
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Price Negotiation and Agreement
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Finalizing Product Design and Packaging
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Manufacturing the Product
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Raw Material Procurement
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GDP compliant Warehouse including Storage and Distribution services
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Document Submission and Regulatory Approvals
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Quality Control and Testing
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Logistics and Distribution
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Post-Production Support
Regulatory Compliance
Regulatory compliance is paramount in clinical trials, especially when sourcing comparator drugs. Our services adhere to all relevant regulatory guidelines, including FDA,EU-GMP, ISO ,GMP , EMA and ICH regulations, to ensure compliance and mitigate regulatory risks associated with sourcing comparator drugs for your trials.
Bioequivalence & Biowaiver
Our Bioequivalence & Biowaiver services provide tailored solutions, including bioequivalence and clinical strategies, as well as biowaiver support with justification documents, empowering successful drug development and approval.