Psychedelic Drug Development

Whether preparing a Phase 1 CMC package or a Module 3 build for marketing application, our expert CMC consultants and writers will help you navigate GMP requirements, right of reference approaches, and unique challenges such as guidelines for botanical drug development.

Our team of nonclinical strategists, writers, and data specialists will help you achieve agreement from global health authorities and conduct your pre-clinical program with confidence through the following:

• Effective use of Type-D meetings to obtain early agreement on the use of published literature and reference submissions to effectively leverage prior nonclinical and clinical data in support of IND enabling studies.
• Early discussions of relevant non-clinical requirements to ensure study designs are appropriate to planned indication and clinical dosing regimen.
• Worry-free IND preparation from experienced nonclinical writers and strategists.

• Create SOPs proactively to ensure that compliance needs are met
• Build credible development program for potential partners and investors
• Develop regulatory and compliance strategy in parallel for synergistic benefits

• Strategic consulting and direct regulatory communication
• Coordinating submissions in tandem with your clinical or regulatory groups
• Consolidating data entry and uploads to CTIS, leveraging our CTIS tracker as a reliable reference for all updates
• Efficient portal monitoring and document management

• A seasoned team adept at personal protected data (PPD) and company confidential information (CCI) redactions
• Orchestrating reviews with your clinical, regulatory, and legal entities
• PoCs skilled at guiding, facilitating, and pinpointing reasons for CCI
• Crafting consistent dossiers reusable for other disclosure needs like ClinicalTrials.gov, Health Canada PRCI, and EMA Policy 0070 submissions
• Comprehensive dossier disclosure support

• Skilled medical writers utilize lean authoring techniques and practices in line with CTR
• GAP analysis and refining your templates for portal compatibility
• Precision authoring to limit the reliance on PPD and CCI