Biotech
Customized Services and Solutions for Biologicals and Biotherapeutics
Biotech is emerging field in medical science and healthcare. All next generation products are getting developed based on targeted therapy, with a goal of more effective results with lesser side effects. Veloris serves as a reliable outsourcing partner for technical and commercial developments, so company can focus its internal resources on its core business goals and achieve more profitability and growth.
Veloris, with its well-connected industry networks, global resources, team of experts and experience in managing complex projects, assist companies across R&D, manufacturing and quality management, business development, global expansions and diversifications.
Global Reach
We develop partnerships with leading companies and organizations from around the globe to complement our expertise and deliver breakthrough results.
Subject Expertise
Our professionals have deep expertise and are able to apply a broad range of methodologies for specialized on-demand analyses.
Experience
Our approach helps clients overcome the odds by predicting, measuring and managing the risk associated with change from day one.
Services and Solutions Offered by Veloris
Contract Research and Development Services
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Formulation Development, Analytical Studies, Biotherapeutics, Clinical Research, Strategic R&D Solutions, Regulatory Documentations and More. Click on below services to know more
Therapeutic Area
- Biosimilar Development
- Cardiovascular
- Cell & Gene Therapy
- Critical Care
- Dermatology
- Hepatology
- Gastroenterology
- Immunology and Rheumatology
- Infectious Diseases
- Metabolic and Endocrine
- Nephrology and Renal Diseases
- Neuroscience Research
- Oncology and Hematology
- Immuno-Oncology
- Ophthalmology
- Pediatrics
- Rare Diseases
- Respiratory
- Urology
- Vaccine Development
- Women’s Health
CRDMO Services
- Antibody discovery
- Hybridoma sequencing
- Humanization
- Affinity maturation
- Transient production
- Membrane protein expression
- ADC development
- ADCC enhancement
- Cell line development
- Cell based assays
- Protein analytics
- Process development
GMP manufacturing
Clinical Studies and CRO Strategy
- BA/BE studies
- Scope Assessment
- Initial CRO Screening/Selection Process
- Request for Proposal (RFP)- Proposal Review and Final CRO Selection
- Negotiation and Project Finalization
- Project oversight, monitoring and resource management
- Regulatory Writings & Documentations
- Final Report Reviews and Filing Preparations
- Resolving recruitment issues
- Clinical Quality Assurance and cGCP compliance
- Developing target product profiles
- Clinical development strategy
- Clinical development plans
- Developing study synopses and trial protocols
- Clinical trials benchmarking
- Disease indication strategy and lifecycle management
- Statistical Analysis Plans and Biostatistics Support
Medical Writing Services
- Pre-IND documentation
- Clinical trial protocols and reports
- Informed consents and assets
- Investigator brochures
- Regulatory submission documents (INDs, NDAs, BLAs, IMPDs)
- Safety and pharmacovigilance documents
- Scientific publications and presentations
- Document management: Streamlining document lifecycle with comprehensive solutions for: Document authoring, review, and approval, Version control and tracking, Quality control and compliance
Regulatory Submissions
- Plan, manage, review, write and submit dossiers as per country specific requirements
- Dossiers as per eCTD compliant format technical sections and summaries for regulatory filings, including IND, IMPD, orphan drug designation applications, amendments, CTA, NDA, ANDA, DMFs, Investigator’s Brochure (IB), annual reports, amendments, etc as per requirements.
Manufacturing and Quality Control
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Contract Development and Manufacturing Services, • GMP Compliance Assessments and Auditing , Product life-cycle management, • Quality Management System (QMS) Implementation and Improvement, • Gap Analysis and Adaptation to New Local Regulatory Requirements and More
Production and QA Department
- Product life-cycle management
- Process validation and validation master plans
- Technology transfer and scale-up
- Cost and process modeling, including new technologies
- Quality Systems and Regulatory Consulting
- GMP Compliance Assessments and Auditing
- Project Management; science-driven oversight and coordination of CROs to ensure “on-time” “on-quality” and “on-budget” delivery
- Q7A, 21 CFR Parts 210-211 and ICH regulatory compliance
- Interpretation of FDA and international regulations and guidelines
- Maintain Quality Assurance responsibilities for virtual companies (e.g., batch record review, release of clinical supplies)
- CMC regulatory strategy; Phase 1 through commercial. QA, QC reviews
- Maintain a Quality Assurance role for virtual organizations
- SOP and Documentation assessment, Drafting SOPs for emerging pharmaceutical and biotech organizations
- Mock Pre Approval Inspections for US FDA, EU GMP and other Agencies
Quality Management Systems (QMS)
- Gxp Quality System Building/Upgrade
- Quality Management System (QMS) Implementation and Improvement
- Gap Analysis and Adaptation to New Local Regulatory Requirements
- Quality Auditing (Qualification, Routine)
- Quality Assurance Team Training and Coaching
- Onsite, Live, and On-demand Courses
Contract Manufacturing
- Third Party contract Manufacturing Management
- GMP Compliance Assessments and Auditing Manufacturers for CMO Projects
- Project Management; science-driven oversight and coordination of CROs to ensure “on-time” “on-quality” and “on-budget” delivery
- Technology transfer and scale-up
- Cost and process modeling, including new technologies
- Maintain Quality Assurance responsibilities for virtual companies (e.g., batch record review, release of clinical supplies)
Project Consultancy
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Complete Project Consultancy Solutions from Startups to Ongoing Projects, Project Oversight and Management, Turnkey Project Development and More
Project Consulting Services
- Turnkey Project Development
- Project Feasibility Studies
- Project Oversight and Management
- Operational & Project Planning
- Engineering Oversight
- Cost Engineering & Cost Control
- Commercialization Planning
- Risk Assessment
- Interim Executive Leadership
- Vendor Review & Selection
Business Consulting
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Domestic and International Business Development Consulting with specialized subject matter expertise, Product Research and Marketing, Valuation & Due Diligence, Mergers and Acquisitions, Private Equity Funding, Project Funding and More.
Market Research and Access
- Market Demand and Supply Identification
- Market specific product identification
- Product Analysis, Due-Diligence, Pricing Strategy
- Go-to-Market Strategy Development
- Data Analysis and Reports
- Competitive Landscape and Sales Roadmap
- Qualitative and Quantitative Market Research
International Business Development
- Market and Product Identification
- Regulatory Landscape
- Pricing Analysis
- Out-Licensing, Partnering and Deal Making
- In-Licensing
- Offshore Business Unit
Due Diligence, Mergers and Acquisitions
- Financial and Scientific Due Diligence
- Pre assessment to identify any “red flag” areas
- Evaluation of specialized company in terms of IP valuation
- Machinery and Equipment’s Physical Evaluation
- Identifying opportunities for Mergers and Acquisition
- Offshore Mergers and Acquisitions
- Strategic Partnerships
Private Equity
- PE Due Diligence and Consulting Services
- Deal Making
- Opportunity Identification
- Exit Strategies
Strategic Business Consulting
- Marketing and Sales
- New Product Development
- Business Development
- Strategic Partnerships
- New Ventures
Start your new project with us
With our wide network of subject matter experts, we provide best services and solutions to match your business needs.
Looking for Reliable Partner ?
Veloris Pharma delivers integrated solutions, complementing our capabilities with a diversified ecosystem of the world’s leading professionals and researchers to achieve better, faster, more enduring results for our clients.
We measure our success by the success of our clients.
Veloris work alongside our clients as one team with a shared vision and goal, to achieve extraordinary results, outperform the competition, and redefine possibilities.
Contact us to know more, ways Veloris Pharma can assist you in new developments and business growth.