Regulatory Sciences
Texium Solutions simplifies regulatory compliance for pharmaceutical, biotech, and medical device companies.
Navigating Global Compliance with Confidence
At Texium Solutions, we streamline regulatory processes for pharmaceutical, biotechnology, and medical device companies, ensuring smooth compliance with global regulations. Our expert team provides tailored strategies to help businesses achieve regulatory success at every stage, from development to commercialization.
Regulatory Operations
Navigating the FDA approval process requires strategic planning and in-depth regulatory knowledge. We provide end-to-end FDA regulatory consulting, helping companies with:
- Regulatory strategy development
- FDA submissions (IND, NDA, ANDA, BLA, 510(k), PMA, De Novo, etc.)
- Compliance audits and gap analysis
- Labeling and regulatory documentation
Regulatory Strategies & Consulting
Effective FDA meetings play a critical role in product development and approval. Our services cover:
- Pre-IND Meetings
- End of Phase 2 (EOP2) Meetings
- Pre-NDA & Pre-BLA Meetings
- FDA Advisory Committee Preparation
Publishing & Submissions
Expanding to European markets? Our experts guide companies through the EMA and local regulatory requirements with:
- Product development strategies for Europe
- Marketing Authorization Applications (MAA)
- Lifecycle management (line extensions, renewals, CMC changes)
- Post-market regulatory compliance
Scientific Writing
Compliance in marketing and advertising is crucial to avoid legal risks. Our team ensures that your promotional content aligns with global regulatory guidelines, including:
- Medical and regulatory review
- Labeling and advertising compliance
- Regulatory submissions for promotional materials
Why Choose Texium Solutions?
Proven Expertise
Decades of experience in research informatics and regulatory compliance.
End-to-End Support
From consultation to implementation, we offer comprehensive solutions.
Scalability & Security
Future-proof solutions designed for high-performance research environments.
Seamless Integration
Compatible with leading industry platforms for a unified digital experience.
Let Texium Solutions be your trusted regulatory partner.
Contact us today to accelerate your regulatory approvals!
