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Biopharmaceutical Development

Clinical Trials >> Compliance, Regulatory & Consulting >> Biopharmaceuticals

Celerion consults in the scientific and regulatory phases of biopharmaceutical product development. Our scientists are very engaged in the practical interpretation of the requirements for biosimilar drugs emerging in Europe.

Key ingredients for successful development, approval and partnering are promising compounds, tailor made approaches and skilled people with an eye for the essential in global senario. Targeted solutions for the development and approval of biopharmaceutical products or biological drugs and support your company and people to excel.Strategy & Integrated Development Planning, Scientific Advice (EU, US, Japan), Due Diligence, Partnering, Regulatory Submissions, Integrated Summary of Immunogenicity, Biosimilarity Assessment Report, Rescue Projects, Training & Coaching. DSI InPharmatics offers one-stop, full-service CMC consulting experience to the development and regulation of drugs and biologics to emerging pharmaceutical and biopharmaceutical companies. For pharmaceutical and biopharmceutical companies with products in development. Regulatory support, product development and quality systems consulting services for biopharmaceutical development. Consulting services and regulatory support are based on a full understanding of FDA or international regulatory expectations and policies. The complexity and depth of challenges faced by the global pharmaceutical and biopharmaceutical industry has resulted in the need for these organizations to change their operating model to reduce costs, while improving their capabilities to enhance the drug development pipeline and bring new drugs to markets. Traditional operating models are being pushed to the point of breaking because of cost pressures, emerging competition, governmental and political demands and the weight of supporting global distribution channels. In response to these pressures, these industries are exploring new growth opportunities in emerging markets, strengthening their research and development by collaborating with industry and academic partners, and focusing on operational efficiency. Managing the complexity of drug development, approval and post-approval product maintenance processes, hiring specialists and resources and the ability to manage fluctuations in resource demands are key issues biopharmaceutical companies are facing. While the issues large and mid-size pharmaceutical companies, as well as biopharmaceutical companies are common, there tend to be differences in the expertise sought in a service provider. The regulatory requirements for manufacturing and approval of biologics and biosimilars are different from traditional, small molecules. Best practices in areas like maintenance of aggregate reporting schedule, as well as the use of standard templates and processes for reports, risk management strategies, adaptive study design and study quality surveillance are to be developed and adopted. Biopharmaceuticals clinical trials or clinical research services providers specialize in knowledge-based processes and provide end-to-end services in a cost effective manner. They adopt flexible approach which allows clients to pick and choose activities within service offerings. Offering an integrated drug delivery solution approach by leveraging domain expertise, process and technology expertise, clients are provided with Integrate clinical, regulatory and commercial strategies to provide unique value, Balance resourcing as the portfolio adjusts to pipeline, regulatory and market fluctuations, Reveal product’s value to regulators, payers, providers and patients, Make “go/no go” decisions through the entire product lifecycle Product innovation drives the biopharmaceutical and medical device industries, but can also be a serious challenge for development of drug-device combinations, biosimilars, companion diagnostics, biomarkers, orphan drugs, and other novel products. Singular clinical knowledge to create new biologic products across multiple therapeutic areas, Strategic market access programs to leverage reimbursement policies in key markets, Custom partnerships to assure geographic market penetration via tactical product agreements.

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