Project Leadership & Business Solutions
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NGT BioPharma Consultants provide a range of Project Leadership & Business Solutions Drug Development consulting services along with Early Development advisory and educational services to support our clients’ efforts to access the financial resources needed to advance their valuable molecules and potential assets towards Phase 1 clinical trials and beyond.
Our experienced team of project leaders and project managers with expertise in small and large molecules (Mabs, duobodies, proteins, cell therapy, gene therapy, and other new modalities) work across all stages of drug development to successfully integrate project workstreams to ensure efficient and effective acceleration of client molecules and potential assets to the next development milestone.
PROGRAM/PROJECT LEADERSHIP & MANAGEMENT
- Management of regulatory and compliance strategies
- Project planning, execution, and monitoring
- Scope management
- Timeline and budget planning and management
- Stakeholder alignment
- Technology due diligence
- CRO/CDMO engagement and alliance management
- Multi-disciplinary team management
BUSINESS SOLUTIONS
- Grant prospect research to match opportunities and needs
- Grant writing, consultation, and training
- Proofreading and editing
- Pre-Seed, Seed, Series A-C Funding support
PRECLINICAL AND CLINICAL DRUG DEVELOPMENT
- Assess IND-enabling studies for submission readiness
- Establish a local or global regulatory strategies, including plans for leveraging expedited pathways and special programs
- Optimize, create and submit meeting requests, meeting packages and briefing books
- Provide IND and CTA maintenance (initial submissions, amendments, annual and periodic reports and closure
REGISTRATION
- Prepare companies for Pre-NDA meetings and scientific advice
- Create and manage Emergency Use Authorizations submissions
- Provide NDA/BLA/MAA dossier authoring and regulatory project management
- Priority review requests
- Managing responses to health authority questions
ADDITIONAL SERVICES
- U.S. Agent for non-U.S. entities
- Regulatory due diligence, gap analyses and risk management
- Rare Pediatric Disease Designations
- Special Protocol Assessments
- Expedited program requests (Breakthrough, Fast Track, Priority Review, Accelerated Approval)
- Orphan Drug Designations
- Regulatory strategy refinement and optimization
PROGRAM/PROJECT LEADERSHIP & MANAGEMENT
- Management of regulatory and compliance strategies
- Project planning, execution, and monitoring
- Scope management
- Timeline and budget planning and management
- Stakeholder alignment
- Technology due diligence
- CRO/CDMO engagement and alliance management
- Multi-disciplinary team management
BUSINESS SOLUTIONS
- Grant prospect research to match opportunities and needs
- Grant writing, consultation, and training
- Proofreading and editing
- Pre-Seed, Seed, Series A-C Funding support
- Investor pitch decks
- Paperwork and documentation
- Finding the right investor
- Business valuation
- Grant prospect research to match opportunities and needs
- Grant writing, consultation, and training
- Proofreading and editing
- Pre-Seed, Seed, Series A-C Funding support
Working with Big Pharma Globally
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Get in touch
For more information pertaining to Regulatory Strategy & Application Preparation please contact Roger or Rachel on the details below. Alternatively please fill in the form and our team in this field will get back to you.
New Enquiry
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