In a highly regulated environment with ever changing requests and compliance issues, the challenges become tougher every day. Hiring the right resource at the right time becomes even more difficult. Let us help with a specialized resource to help you meet deadlines and off-set peak demand. Our team will allow you to focus on the task at hand enable you and your teams to focus on strategic initiatives while we help with both tactical and strategic implementations with the end in mind.
Regulatory Focus Areas
-
Domestic & International Registrations
-
CE Marking
-
EU MDR Upgrades
-
Regulatory Submissions (NDA, BLA, IND 510K, PMA’s, etc.)
-
Technical Files/Design Dossiers
-
Advertising & Promotions
-
Regulatory Labeling
-
Regulatory Strategists with Therapeutic
-
Specialties
-
Publishing
-
CMC
-
Regulatory Information Management Systems
Audit Specialization
VGS can provide a specialized audit based upon your company’s needs including: vendor audit, regulatory, mock audit, decommissioning, and/or a risk strategy. All audits and assessments are conducted in accordance with the FDA’s Pre-Approval Inspection Program that address facility, product, and process concerns.
Focused Expertise
VGS can lead, assist, or even compliment a sponsor’s approach to approvals and submissions for both U.S. and International markets (510(k), ANDAs, NDAs, BLAs, INDs, APR).
Complex Issues
Many sponsor companies look to us to help with complex issues related to CMC expertise and to lead or support filings of developmental or approved products. VGS has also supported efforts with specific expertise around product labeling requirements.
Case Studies
At Vita Global Sciences, we’ve had the privilege of partnering with some of the most innovative names in the pharmaceutical industry. Our case studies showcase the breadth of our work, highlighting key projects that have revolutionized drug lifecycle development. From early-stage research to market-ready solutions, we invite you to explore these success stories that underscore our commitment to excellence and innovation.
