Pharmaceutical Regulatory Affairs

Regulatory Support for Drugs, Herbal Products, Nutritional Supplements, and OTC Products

Streamlined Submissions. Global Compliance

High-precision analytical testing
We deliver validated analytical solutions tailored to the pharmaceutical industry. Our lab uses advanced instrumentation to test purity, stability, and performance with accuracy and reproducibility.

From method development to impurity profiling
With expertise in developing and validating robust methods, we support early-stage R&D, regulatory submissions, and commercial product monitoring with reliable data and documentation.

Our Key Regulatory Services

✓ Dossier Preparation & New Product Developme

  • Global dossier compilation (eCTD, CTD, ACTD formats)
  • Administrative document assistance
  • MOH liaison for submissions
  • Post-submission regulatory support

✓ Active Substances – DMF/ASMF/CEP Submissions

  • Technical writing for DMF/ASMF submissions
  • International regulatory data alignment
  • Open & Restricted DMF part management
  • CEP submissions for EU compliance

✓ Clinical Services & Research Support

  • Literature reviews for clinical studies
  • Clinical trial monitoring & management
  • Bioavailability (BA) & Bioequivalence (BE) oversight
  • Regulatory documents: PSUR, RMP, Toxicity Studies

Our Business Model

Our business model outlines how we create, deliver, and capture value. It serves as a blueprint for sustainable operations and long-term growth.

A well-defined model provides strategic and operational advantages across our service spectrum.