Clinical Trial Regulatory Affairs
Our team has the experience necessary and puts in the time to ensure that all submissions are prepared and submitted correctly the first time.
Navigate the Regulatory Landscape
WCCT Global offers full-service clinical regulatory affairs support from pre-IND meeting preparation through NDA submission, and all FDA correspondence which occurs in-between. Our team consists of experts in crafting, reviewing, and submitting compliant documents to the FDA (and other regulatory bodies), ensuring that your regulatory requirements don’t impede your product development goals. We have direct interaction with the FDA for numerous therapeutic areas and different types of drug products, representing our clients in communications with the Agency. WCCT provides the following clinical regulatory affairs services:
- Pre-IND meeting support: Crafting meeting questions for optimal Agency outcomes; preparation and submission of meeting requests and briefing packages; attending and facilitating meetings and rehearsals
- Original IND submissions: Gap analysis to ensure full compliance with IND expectations; drafting, reviewing, and revising all Modules of the IND; project management and oversight for effective timeline maintenance
- IND maintenance activities: Preparation and submission of IND Annual Reports; creating safety reports; handling information and protocol amendments
- US Agent services: Acting as the FDA representative for sponsors; liaising with the Agency for effective communications and handling of information requests
- Regulatory strategy and guidance: Identifying critical path issues and approval pathways; preparation and submission of regulatory review designations (i.e. orphan drug, fast-track, breakthrough, etc.)
- Electronic submission publishing services using internationally-recognized and validated publishing systems
WCCT can provide full suite services, or a la carte regulatory support or guidance whenever needed. Whether a sponsor has no in-house regulatory department, or just needs support with regulatory legwork, we are available and flexible to respond to these needs.
We understand that providing accurate, error-free, and eCTD-compliant submissions can be a daunting task, and that submissions with mistakes can put your product at risk with the FDA–we are committed to ensuring that all submissions are completed correctly the first time, saving you critical development time.
WCCT’s Clinical Trial Regulatory Affairs Team
Our Regulatory Affairs team has a combined 45 years of experience in the industry, and works closely with our on-staff team of medical writers. Because our group is smaller than other large CROs, WCCT is able to take a deeply hands-on and detailed approach to our regulatory projects. Our smaller size means that we are always available and responsive, without delay in communications which can be vital when interacting with the Agency. Our regulatory group strives to seamlessly integrate into our clients’ teams, such that they are intimately aware of all program details, regulatory goals, and critical path issues.
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