Windlas Biotech Ltd.

WBL focuses on meeting client needs through flexibility, creativity and service excellence. Our turnkey services are lead by project managers with extensive business management experience and realistic foresight. Through effective communication, interactions and follow-through with our customers throughout the project life cycle and beyond, we ensure that all requirements and project specifications of our customers are met with absolute quality and timeliness.
Our dedicated team at WBL encompasses experts in Drug Development, Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Logistics, Planning and Purchasing.
Our services range from pre-formulation development and scale-up to commercial cGMP manufacturing of pharmaceutical drugs. Our range of services include:

1. Pre-formulation & Formulation Development:
- Raw material sourcing
- Characterization of physical properties
- Powder characterization
- Dissolution testing
- Excipient compatibility studies
- Stability assessment
- Formulation and packaging compatibility
- Formulation development for early safety studies

2. Analytical Development:
- Molecule characterization
- Method development & validation
- Cleaning residuals development & validation
- Dissolution and drug release profiling
- Forced degradation studies
- Specifications development
- Stability monitoring to ICH guidelines

3. Process Validation

4. Manufacturing, Packaging & release testing of registration batches

5. Distribution & Logistics

6. Adequate documentation for drug application

7. Experienced PAI (Pre-Approval Inspection team)

8. Complete data for notification dossier