What We Offer
Pharmaceutical Industry Consulting Services:
Expert guidance in regulatory affairs for 503(b) compounding facilities, generic drugs, biosimilars, and medical devices.
Development and implementation of regulatory strategies to secure approvals from FDA, Health Canada, and other global agencies.
Ongoing updates on regulatory changes and industry trends through continuous self-study, certifications, and participation in professional forums.
Leveraging AI-driven insights to inform decision-making and optimize project execution.
Global Regulatory Navigation:
Assistance for international clients in understanding and complying with regulatory requirements across multiple regions.
Expertise in navigating FDA, Health Canada, EMA, and other global regulatory agencies.
Comprehensive support in preparing, reviewing, and submitting global regulatory dossiers.
Insights into regional variations in regulations to help clients optimize their market entry strategies.
Tailored solutions for addressing country-specific challenges, ensuring a smooth path to global compliance.
Licensed Pharmacists On-Demand:
State-specific expertise with pharmacists licensed in 38 states.
Remote pharmacy solutions, including medication counseling, remote order entry, and support for multi-state online pharmacies.
Remote Medication Therapy Management (MTM) to improve patient outcomes and reduce healthcare costs.
Liaison services with Boards of Pharmacy across all 50 states to ensure regulatory compliance.
Support for international clients in preparing and submitting state-specific regulatory documents for controlled and non-controlled medications.
AI Integration in Drug Development and Pharmacy:
Guidance on implementing AI tools for drug discovery, clinical trials, and pharmacovigilance.
Strategies for integrating AI into pharmacy operations, including inventory management, medication therapy management, and virtual pharmacy services.
Education and training for staff to ensure seamless adoption of AI technologies.
Customized solutions to align AI capabilities with your business goals and regulatory requirements.
Why Partner with Us?
Comprehensive Expertise: Extensive knowledge in both regulatory affairs and state-specific pharmacy regulations.
Global Perspective: Expertise in navigating FDA, Health Canada, and other international regulatory authorities.
On-Demand Solutions: Access to licensed pharmacists for seamless, compliant operations.
Proactive Approach: Staying ahead of regulatory changes to provide cutting-edge guidance.
