Centralized Regulatory Consulting Model
Maven specializes in helping industries with distributed regulatory departments transition to a centralized consulting model. We design and implement centralization programs that streamline key regulatory functions across global operations.
Core Centralized Services
- Dossier Preparation & Lifecycle Management
- Publishing & Submissions
- Regulatory Information Management
- CMC & Change Control
- Labeling & Artwork Coordination
Specialized Regulatory Support
- Pre-IND and NDA Meeting Preparation
- Pharmaceutical & Biologics Registration
- Medical Device Testing & Clinical Evaluation Reports (CER)
- Electrical & Electronics Product Testing & Technical Files
- Textile Labeling, Packaging & Fire Resistance Testing
- EU REACH, TSCA, GHS SDS & Chemical Compliance
- Children’s Product Safety & Hazardous Labeling
Toxicological & Clinical Consultation
- Risk Assessment Reports & Margin of Safety (MoS)
- Safety Data Sheet (SDS) Authoring (GHS Format)
- Cosmetic Product Safety Reports (CPSR) – EU Regulation 1223/2009
- Post-Market Clinical Follow-up (PMCF) for Medical Devices
- Clinical Trial Design, Protocol Development & CSR
With deep industry experience and a commitment to quality, Maven delivers regulatory consulting services that meet global standards and client expectations.
