LTD CONSULTING, LLC
The Right Drug, The Right Patient, The Right Time
INTEGRATED FRACTIONAL CMC & CLINICAL SUPPLY CONSULTING
We can help you create and manage an efficient, cost-effective clinical supply chain and regulatory strategy to meet the needs of your trials and your patients.
Our team has extensive experience across all aspects of clinical supplies, regulatory affairs and quality assurance.
forecasting
VENDOR MANAGEMENT
PACKAGING & LABELING
procurement
Storage & distribution
ELECTRONIC BATCH RECORD REVIEWS
interactive response TECHNOLOGY
AUDIT READINESS
inventory management
SOP CREATION AND REVIEW
returns & destruction
Regulatory strategy
We combine a wealth of clinical supply chain, regulatory and QA knowledge with a team-based approach to provide our clients with best-in-class clinical trial supply chains. Our services include, but are not limited to, the following:
- Clinical Supply Project Management
- Supply forecasting and planning
- IRT/RTSM setup and management
- Temperature excursion management
- Drug accountability and reconciliation
- Shelf life extensions
- Regulatory Affairs strategy
- Quality Assurance support
Experience
Our Team
Our senior-level team of consultants has decades of clinical supply chain, regulatory, and quality assurance experience across small and large pharmaceutical companies. We can provide immediate results for any situation. Contact us today to put together a custom-tailored CMC & clinical supply consulting package that meets the unique needs of your clinical trials.