We are the extension of your product development team.
Keeping up to date with global regulatory and reimbursement environments can be very time consuming. We are the extension of your product development team with on-and off- and near-shore resources for greater efficiency and maximum value. We can be your lead regulatory department with a long-term partnership. We are functional experts that can support your team seamlessly.
Operational models tailored to your needs
A la carte solutions that complete your picture. Our operational models enable clients to reduce the cost, while improving the resource flexibility and still maintaining quality.
The tactical work
- Regulatory Strategy/US/Regulatory Agent Support
- Preparation and Review of CMC, nonclinical and clinical documents
- Drug Master Files
- Veterinary Master Files
- Technical Writing
- Annual Reports/DSURs/PADERs
- Variations / Supplements’ preparation
- Application lifecycle management throughout development (protocol amendment, new nonclinical data as IND amendments, and for investigation of product line extensions)
- Review of GMP / Validation documents
- Publishing support in eCTD format
- Compile and review labeling including PLR format; labeling conversion to SPL format
- FDA interactions/support
- Life-cycle management
- Prepare Fast Track and Breakthrough Therapy Designations
- Support Orphan Drug Designation Requests
- Prepare/submit electronic Labeler Code Requests eDRLS, Drug Distribution Reports
Hands-on experience and deep expertise across drug development cycle
Over time, product development calls for a broad range of specialist skills. Our team features a level of industry experience in innovative product development that is not easily found or assembled while saving you hiring personnel for a limited, specific need. Consultancy engagement is an efficient, cost-effective way to manage issue-resolution.
Our successful track record proves that when it comes to handling unprecedented issues, with no applicable framework or unexplored product complexity, experience matters. Along product life cycle, an integrated set of product- and market-specific expertise enables us to address intricate problems and anticipate future challenges.
Global network with a global mind at your reach
VCLS operates in 3 continents, 6 countries with more than 150 life science professionals. Global network and harmonization allow our teams to reach across the world seamlessly to serve you effectively as one.
“VCLS is our favorite company to work with. We feel you are part of our team and they are not all like that. Your people are the absolute best of the best. It seems as though they are always working no matter when I contact them. You are extremely knowledgeable and good at what you do. You make our job easier.”
VP, Regulatory
Top 10 Pharmaceutical Company
Solutions 
