AS Pharma Consulting provides hands-on and strategic regulatory, clinical and nonclinical consulting support to pharmaceutical organizations from small biotech to large commercial-stage companies. Services include:
• Regulatory strategy, submission planning for US INDs, Canada CTAs, EU and UK CTAs, IMPDs
• Regulatory writing of IND and NDA documents (Modules 1 - 5), orphan requests, fast-track, breakthrough therapy designations, INN, USAN, annual reports, DSURs, health authority meeting requests and briefing documents
• Project management, tracking and execution of regulatory submissions and clinical development activities
• Medical writing and review of clinical trial protocols (first-in-human, Phase 2, pivotal, Phase 3 trials), investigator brochure, IND summary and overview documents, meeting requests, briefing documents and responses to health authority inquiries.
• Clinical protocol development, preparation, review and execution
• Due diligence for in-license and out-licensing of preclinical and clinical assets
• Regulatory intelligence and development of target product profiles
• Lead and prepare teams for health authority meetings and interactions with FDA, EMA, MHRA, PMDA
• Regulatory leader for project teams and coach/mentor/groom regulatory managers to assume lead role
• Nonclinical, toxicology, DMPK and clinical pharmacology data review, interpretation and problem solving
• Author, review and provide strategic input for clinical and nonclinical regulatory documents
• Develop Standard Operating Procedures (SOPs) to support drug development and regulatory best practices and toolkits to ensure quality and consistency throughout a growing organization
• Partner with regulatory publisher to ensure complete and compliant health authority submissions
Company Details
- Founded
- -
- Address
- Wilmington, 19807, Us
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- http://www.aspharma.com
- Keywords
- Regulatory Affairs, Clinical Development, Clinical Strategy, Regulatory submissions, Regulatory strategy, IND, NDA, Health authority interactions, Oncology, Hematology, Inflammation, Clinical pharmacology, Toxicology, DMPK, Clinical trials, Clinical protocols, Mentorship, Neuroscience, Project management.
- HQ
- Wilmington
As Pharma Consulting, Llc Questions
As Pharma Consulting, Llc's website is http://www.aspharma.com
As Pharma Consulting, Llc's LinkedIn profile is https://www.linkedin.com/company/as-pharma-consulting
As Pharma Consulting, Llc's industry is
Business Consulting and Services
As Pharma Consulting, Llc's top competitors are
As Pharma,
Moh Pharma,
Me Pharma,
Pharma Consulting,
Ascensia Pharma,
Nanocan Therapeutics Corporation,
Adwa Pharma,
Pharma Vitality,
Diar Pharma,
Pharma Concept.
As Pharma Consulting, Llc's categories are Business Consulting and Services
As Pharma Consulting, Llc's founding year is 2022
