Regulatory Support
& CMC Services
SGS delivers comprehensive regulatory guidance and Chemistry, Manufacturing & Controls (CMC) support to help you meet global requirements and progress your drug products efficiently through development, approval and lifecycle management. .
Our worldwide network of regulatory, quality, and technical specialists works alongside your teams to address complex challenges at every stage, providing clear, dependable advice grounded in deep familiarity with ICH, EMA, FDA, and other major authorities to strengthen compliance and reduce risk throughout your programme. Our regulatory affairs experts support chemical and biological products from early development through clinical and commercial phases, offering strategic direction, preparing essential documentation, and guiding you through global submission pathways, drawing on extensive experience supporting applications across multiple countries.
Why SGS?
Navigating increasingly complex regulatory and CMC expectations is critical to the successful progression of your molecule. SGS provides globally recognised regulatory expertise alongside integrated CMC, analytical and GMP‑aligned support, ensuring your development, scale‑up and technology transfer activities are scientifically robust and fully compliant. With end‑to‑end capabilities spanning formulation, analytical method development, stability, manufacturing and QP release, SGS helps you de‑risk your program and move confidently toward clinical and commercial milestones. With this combination of global insight and hands‑on technical partnership, you can bring safe, high‑quality medicines to market with greater speed and certainty.
Regulatory Affairs Expertise
Our regulatory affairs experts support chemical and biological products from early development through clinical and commercial phases. We offer strategic direction, prepare essential documentation and guide you through global submission pathways, drawing on extensive experience supporting applications across multiple countries.
We provide professional support across the full regulatory continuum, including:
- Assistance with clinical submissions such as Investigational New Drug (IND) applications and Investigational Medical Product Dossiers (IMPD).
- Preparation of pre-market fillings including Marketing Authorization Applications (MAA) and Biological License Applications (BLA)
- Post-approval support, including variations and Post-Approval Supplements (PAS)
- Independent, objective recommendations on the most effective regulatory approach.
