Formulation Research and Development for Orodispersible Film (ODF) and Transdermal Patch (TDS)

Process optimization in Formulation of Solid oral dosage forms.Execution of Trial and Scale-up batches at commercial site.Preparation of documents like PIF, PDP, MFC, BIF, Sampling protocol, Study plan and Batch summary scale up report and PDR.Recommendation for the process parameters in Trial and Scale up batches.Execution of Trial, Scale up, exhibit batches in coordination with AFD, QC, QA and Production department.Coordination with various departments like Analytical R&D, QC, QA, RA and Production department for regular activity Effective daily planning and execution related to work.Research and New Development of Orally Disintegrating strips (ODS).Well acquainted with various ICH, USFDA and CDER guidelines. Preparation and maintenance of SOPs for documentation and equipments.Preparation of form 29 test license files and applied for NOC for test license.Preparation of DCGI files and applied for Form 44.Involved in BE study of solid oral dosage form products.

Process optimization in Formulation of Solid oral dosage forms.Execution of Trial and Scale-up batches at commercial site.Preparation of documents like PIF, PDP, MFC, BIF, Sampling protocol, Study plan and Batch summary scale up report and PDR.Recommendation for the process parameters in Trial and Scale up batches.Execution of Trial, Scale up, exhibit batches in coordination with AFD, QC, QA and Production department.Coordination with various departments like Analytical R&D, QC, QA, RA and Production department for regular activity Effective daily planning and execution related to work.Research and New Development of Orally Disintegrating strips (ODS).Well acquainted with various ICH, USFDA and CDER guidelines. Preparation and maintenance of SOPs for documentation and equipments.Preparation of form 29 test license files and applied for NOC for test license.Preparation of DCGI files and applied for Form 44.Involved in BE study of solid oral dosage form products.

1) Maintaining the project planning system for assigned projects.2) Preformulation and stability studies. 3) Designing and Conducting the experiments4) Formulation Development and process optimization of Oral Disintegrating Strips/ Orally Dissolving Films/ Mouth Dissolving Oral Thin Film Strips/ Rapid Mouth melting Strips/ Oral thin Film5) Coordination with various departments like Analytical R&D, QC, QA and Production department. 6) Preparation of MFC, BIF and other supporting Documents 7) Preparation of PIF, PDP and PDR

1) Maintaining the project planning system for assigned projects.2) Preformulation and stability studies. 3) Designing and Conducting the experiments4) Formulation Development and process optimization of Oral Disintegrating Strips/ Orally Dissolving Films/ Mouth Dissolving Oral Thin Film Strips/ Rapid Mouth melting Strips/ Oral thin Film5) Coordination with various departments like Analytical R&D, QC, QA and Production department.

1) I have experience in developing the Oral Disintegrating Strips/ Orally Dissolving Films/ Mouth Dissolving Oral Thin Film Strips/ Rapid Mouth melting Strips/ Oral thin Film and the taste masking of Oral Disintegrating Strips/ Orally Dissolving Films/ Mouth Dissolving Oral Thin Film Strips/ Rapid Mouth melting Strips/ Orodispersible strips2) Literature review and patent searching. 3) Maintaining the project planning system for assigned projects.4) Preformulation and stability studies. 5) Designing and Conducting the experiments6) Formulation Development and process optimization of Oral Disintegrating Strips/ Orally Dissolving Films/ Mouth Dissolving Oral Thin Film Strips/ Rapid Mouth melting Strips/ Oral thin Film7) Coordination with various departments like Analytical R&D, QC, QA and Production department. 8) Submitting the samples for analysis.9) Involving in Internal audits and effective planning and execution.10) Preparation of MFR, BMR and PDR. 11) Improving, designing and developing new and existing formulations and processes technologies (Oral Disintegrating Strips/ Orally Dissolving Films/ Mouth Dissolving Oral Thin Film Strips/ Rapid Mouth melting Strips/ Oral thin Film, solid oral dosage form) and their documentation. 12) Monitoring of new machines, equipments.13) Process standardization for Formulation Development, Bench scale, Lab scale phase, Scale up, Process Validation and Commercialization of Oral Disintegrating Strips/ Orally Dissolving Films/ Mouth Dissolving Oral Thin Film Strips/ Rapid Mouth melting Strips/ Oral thin Film14) Production problem investigation and trouble – shooting.

I have experience in Solid oral dosage form.