What We Offer
Regulatory Affairs Consulting Services:
Help develop and implement regulatory roadmaps that align with FDA, Health Canada, EMA, and global agency requirements to accelerate approvals.
Provide expert guidance on CMC development, regulatory expectations, and dossier preparation to support product quality and stability.
Support regulatory lifecycle management, post-approval variations, and ongoing compliance monitoring to ensure long-term regulatory success
Review and guide compliance for drug labeling, advertising, and promotional materials to ensure adherence to FDA, FTC, and global marketing regulations.
We assist with pre-IND, pre-NDA, and pre-submission meetings, helping companies engage with regulatory authorities early to gain valuable insights and feedback.
Global Regulatory Navigation:
Assistance for international clients in understanding and complying with regulatory requirements across multiple regions.
We develop customized compliance plans for different geographic regions, ensuring smooth approvals for new products and regulatory renewals.
Assist in obtaining fast-track, orphan drug, breakthrough therapy, and priority review designations to accelerate approvals in multiple markets.
Offer insights into regional regulatory nuances to help clients optimize submission strategies, reduce approval timelines, and minimize regulatory hurdles.
Act as authorized representatives for clients in regulatory interactions, ensuring effective agency communication and compliance resolution.
Licensed Pharmacists On-Demand:
Assist with state board of pharmacy licensing, compliance audits, and regulatory filings to ensure adherence to state and federal laws.
We provide telepharmacy services, remote medication counseling, and compliance consulting for multi-state and online pharmacies.
We offer comprehensive MTM services to enhance patient outcomes, medication adherence, and overall healthcare efficiency.
Work directly with state boards of pharmacy across all 50 states, ensuring compliance and resolving regulatory issues.
We offer regulatory and operational consulting for 503A and 503B compounding pharmacies, ensuring compliance with USP <797>, <800>, and FDA guidance
AI Integration in Drug Development and Pharmacy:
Design tailored AI integration strategies that align with your business goals, operational needs, and regulatory landscape, ensuring a smooth and compliant AI adoption process.
Help integrate AI into inventory management, prescription processing, medication therapy management (MTM), and virtual pharmacy services, optimizing efficiency and reducing errors.
Provide staff training and change management strategies to ensure seamless adoption of AI technologies within pharmacy and drug development environments.
We ensure that AI-driven innovations align with FDA, HIPAA, GDPR, and global regulatory requirements, reducing compliance risks.
