Regulatory
Atheln’s industry-seasoned team can support a company in need of extra capacity for regulatory operations workload or with a full regulatory affairs team
Atheln can support a company in need of extra capacity for regulatory operations workload or with a full regulatory affairs team.
Many of the early-stage companies developing drugs and combination products face challenges designing a solid regulatory strategy that can support their innovative technologies. Atheln’s team of seasoned regulatory professionals, including former regulators, flourish in the application of their extensive experience to new challenges.
Atheln’s Regulatory services include:
- Preparing Target Product Profiles (TPP)
- Designing regulatory strategies from Phase 1 to approval
- Supporting discussion with regulators in Pre-IND (PIND) or scientific advice meetings
- Writing regulatory filings, including:
- INDs, CTAs, NDAs/ANDAs, BLAs, IDE submissions
- PIND, EOP-2, pre-NDA/BLA briefing packages
- PIPs, ODD, DMFs
- Supporting all operational aspects of global regulatory matters for all types of regulatory submissions, all stages of development and commercial products, including:
- Interfacing / managing publishers
- Maintaining agency communication logs
- Interfacing with FDA, EMA and other worldwide Regulatory Authorities
