Services – Reis Regulatory

Regulatory Strategy

Development and execution of innovative regulatory strategies to support your company in efficiently achieving its short-term and long-term business goals. This may include product classification, assessment of preclinical, clinical, and manufacturing requirements, applicability of expedited approval pathways (priority review, fast-track, breakthrough therapy, accelerated approval), development of labeling claims aligned with your marketing strategy, analysis of quality system requirements, lifecycle management, and more...

Regulatory Applications

Preparation of high-quality regulatory applications to obtain authorization for clinical trial conduct (IND, CTA, ITA), marketing approval (NDA/NDS, ANDA/ANDS, 505(b)(2), EU MAA, 510(k), De Novo, PMA, MDL, NHP PLA), and post-approval changes such as new indications, new dosing regimens, or changes to manufacturing (sNDAs, CBEs, PAS). Also experienced with Drug Master Files, Special Protocol Assessments, Pediatric Plans, Rare Pediatric and Orphan Drug Designations and authoring of CTD modules.

Health Authority Communication

Health Authority meetings can be a key tool to reducing regulatory risk by obtaining agreement from Health Authorities on product development plans at critical milestones. Strategically planned and well-written briefing documents are critical to ensuring your meeting goals are met. Highly experienced in planning, preparing for, and attending FDA, Health Canada, and EMA meetings, including pre-IND, pre-CTA, pre-ITA, End of Phase 2, pre-NDA/NDS, FDA device Q-submission meetings, and EMA Scientific Advice.

Compliance & Due Diligence

Ensure pre-market and post-approval compliance with applicable regulations and guidelines. Capabilities include clinical trial master file reviews, GCP audits, vendor qualification and GMP audits, readiness for ISO 13485 registrar audits, claims assessment and promotional material reviews, compliance training for medical affairs and sales teams, and regulatory due diligence to support product acquisitions.