Regulatory Affairs
Navigating the regulatory maze in the life sciences sector demands expertise and precision. Our team stands ready to guide you through both pre- and post-marketing stages, ensuring compliance and excellence at every step.
Our Expertise Covers:
Pre-marketing Preparations: From regulatory filings to marketing authorization applications, our experts manage the intricate details, ensuring your product meets all regulatory standards.
Post-marketing Vigilance: We handle variations, renewals, and the ongoing compliance of your marketed products, providing robust due diligence strategies tailored to your needs.
Technical Review & Interpretation
Client Dossiers & Plans: Our team meticulously reviews client technical documents and developmental plans to ensure alignment with regulatory standards.
Regulatory Status Determination: We research and interpret regulations, determining the precise regulatory status of your products.
Document Preparation & Clinical Trial Support
Technical Document Reviews: Our experts conduct pre-submission reviews of technical documents and offer critical writing and review services to ensure clarity and compliance.
Clinical Trial Applications: We assist in the preparation and submission of clinical trial applications and notifications, including IND, IDE, and CTX.
Marketing Applications: Our team supports various marketing applications, including NDA, BLA, ANDA, 510(k), and PMA, ensuring thoroughness and accuracy.
Specialized Petitions
Orphan Drugs & Treatment Use: We prepare petitions for Orphan Drugs, Treatment Use, and ANDA Suitability, facilitating your path through specialized regulatory pathways.
Quality Control & Compliance
Extensive Reviews: We provide comprehensive quality control reviews for all trial-related documentation, including regulatory agency submissions, import/export licenses, and more.
Document Management: Our specialists manage all regulatory documentation throughout a trial’s lifecycle, ensuring seamless coordination and compliance.
Scientific Writing & Expertise
Regulatory Submissions: Our regulatory scientists craft nonclinical, clinical, and CMC sections for new drug and biologic applications, both in CTD and traditional formats.
Stay Informed, Stay Compliant
Our commitment extends beyond mere compliance. We stay updated with the latest regulatory changes, ensuring your documentation remains compliant and up-to-date.
Partner with us to navigate the complexities of regulatory affairs confidently. Together, we can streamline your regulatory processes, ensuring your innovations reach those who need them most.
Consulting Projects
Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.
Staff Augmentation
Get contracted full-time consultant (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.
FTE Recruitment
We rapidly identify and place direct hire candidates in a variety of positions and job functions. Our recruiters draw on extensive industry expertise to fully understand your hiring needs and conduct a rigorous identification and screening process to provide a shortlist of highly-qualified candidates, especially in aggressive and complicated areas.
