Integrated Formulation Development & Regulatory Dossier Solutions
QBridge Pharma provides comprehensive Formulation, Analytical and Dossier services to support pharmaceutical companies in developing compliant products and achieving timely regulatory approvals across domestic and international markets.
Our services are aligned with ICH guidelines, GMP requirements and global regulatory expectations, ensuring scientific robustness and regulatory acceptance.
Our Manufacturing Support Services
Integrated scientific and regulatory support covering formulation development, analytical validation and global dossier preparation. We assist pharmaceutical companies from product development to regulatory approval, ensuring compliance with ICH guidelines and international health authority requirements.
Formulation Development Services
We use our expertise in successful execution of GMP inspections for various Health Authorities. Our service covers:
- Guidance to selection CRO and conduct formulation development for Injectable / Solid Oral/ External Preparation.
- Guidance for RLD arrangement from their respective markets.
- Guidance for Development Report as per ICH Q8.
Guidance for QBD formulation development. - Guidance for dissolution profile.
- Guidance to selection laboratory to conduct membrane filter validation
Analytical Development Services
- Guidance for Analytical Method Validation and Verification.
- Guidance for Cleaning Method Validation.
- Guidance for Microbial Limit Test Method Validation.
- Guidance for Preservative Validation.
Dossier Services
We use our expertise to review and compliance all the technical package which is required for dossier preparation in CTD/ACTD and eCTD format and submit to MAA/US FDA/ANVIZA/TGA/MCC/PICS/SAHPRA etc.
- Guidance for identify the Bioequivalence centre to conduct BE/BA study.
- Guidance for BE/BA study monitoring.
Review and compliance of CMC documents. - Guidance for clinical and non-clinical study.
- Dossier preparation in CTD and eCTD format.
- DMF Preparation and filling.
- Guidance for Dossier submission to their respective authorities.
- Guidance for RFI and prepare the response against RFI.
Accelerate Product Development & Regulatory Approvals
Partner with QBridge Pharma for reliable formulation development and dossier services aligned with global regulatory expectations