Our Regulatory Affairs team has successfully delivered tailored, global regulatory strategies from discovery to Phase 1 IND/IMPD/CTA, through all the clinical stages to MAA/BLA/NDA and beyond. We can analyse your clinical development path and then map out important regulatory milestones, critical regulatory communications and potential regulatory challenges that need to be addressed.
Cilatus’ Regulatory Consulting services include authoring meeting requests, briefing documents, meeting preparation, participation in agency meetings and meeting follow up including meeting minutes, assessment of agencies’ feedback and follow-up strategies. We have led and assisted our clients through all regulatory procedures including Clinical Trial (IND/IMPD/CTA) and Marketing Authorisation (BLA, NDA, MAA) application processes, scientific advice, and all pre- and post-approval license maintenance activities.
We have extensive CMC experience and the broad global Regulatory CMC knowledge needed to effectively resolve regulatory CMC challenges and to develop scientifically sound solutions. We have worked on large and small molecule products and ATMPs. Our CMC regulatory consulting services include critical review and assessment of Module 3, authoring and review of CMC regulatory documentation (Module 3), CMC Regulatory gap analysis and mitigation, tech transfer, comparability strategies, change control and Marketing Authorisation (MA) compliance, and CMC Regulatory reviews for Due Diligence activities.
We support the product development with our in-house developed Quality by Design (QbD) approaches, procedures, and risk assessments. We can integrate our QbD approach in early development stages or implement them in late-phase development for Process Characterization and Validation as needed by our clients.
On multiple occasions, we have unbureaucratically supported clients on very short notice for urgent projects and developed agency response plans including drafting of detailed agency communications. We also have provided long-term strategic and operational regulatory support for all stages of development and commercial product lifecycle management.