Formulation and development of solid oral dosage forms for US/EUROPE/BRAZIL market....IR Formulation/ Platform technology...Review feasibility evaluation of newly received niche molecules from BD team.Discuss technical points with cross functional team including IPR, Regulatory CMC/cology,Purchase department and Project management team.Developed new formulation concept. Assist in the development of project plan, business analysis and feasibility assessment.Preformulation, Formulation and process optimization study by QBD approach including QTPP, identification of CMA, CPP, risk assessment, risk mitigation and control strategy.working on dissolution science including discrimination study, sink Conditions, multimedia dissolution profiling,bio relevant media and alcohol induced dose dumping study.Monitoring scale up and validation batches. provide technical support to TT and CMO team.provide technical input in troubleshooting and addressing the regulatory queries received from agency.Provide technical output in clinical review and way forward decision to plan BE studies. Review BE data and discuss with team for wayforward. Working on BCS based biodiversity approach n implementation of IVIVC concept on modified and reoptimized formulations.Check and review audit plan provided by QA team.Development of branded generic molecules including risk assessment and mitigation.Project Management: Hands on experience in preparing detailed Project Schedules using standard tools like Microsoft Project Planner. Experience in Budget and Forecast planning, tracking actual Costs at R&D site and Commercial site with the help of core team. Experience managing end-to-end projects desirable.Ability to present numbers in different dimensions as per the need. Facilitate and lead effective project meetings for meeting short-term and long-term objectives of the projects; develop and maintain project plan for all the projects and ensure these updated plans are available to the internal and external stakeholders. Facilitate discussion with project team to identify and assess risks/issues/, brainstorm and document risk mitigation plan and track them till the closure, ensure timely escalation as needed.Work with the project lead to present regular project updates to project governance forums and senior management to help to make effective decision. Project planning and tracking of activities/tasksEscalate and identify other routes where progress is stuck.Actively participate in budget preparation, Budget management controlling of Capital Projects.
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Sr. Research ScientistB&S Group (Uk) Jan 2015 - Jan 2017Vadodara Area, IndiaFormulation and Development of solid oral dosage forms (Tablet): Immediate release (Tablets & Hard gelatine capsules) and Modified Release Tablets (Sustained release formulation for Domestic & Regulated markets.(US & Europe Market)Formulation and Development of general parenteral formulation for Domestic & ROW market. (FFS pack)Provide technical input of query raised from regaff with respect to country.Have been involved in Cost reduction activity of Existing product for solid oral… Show more Formulation and Development of solid oral dosage forms (Tablet): Immediate release (Tablets & Hard gelatine capsules) and Modified Release Tablets (Sustained release formulation for Domestic & Regulated markets.(US & Europe Market)Formulation and Development of general parenteral formulation for Domestic & ROW market. (FFS pack)Provide technical input of query raised from regaff with respect to country.Have been involved in Cost reduction activity of Existing product for solid oral (Conventional Tablet/SR Product) and liquid (Suspension & Syrup) dosage forms.Patent search for desired Formulation and Development with WIPO, USPTO, Patent lens, Free Patents on line, Patent storms, Google patents.To perform Preformulation Study for the development of new drug products and interpretation of DSC and FTIR data. For Active pharmaceutical ingredients- check it physical, chemical & Biological properties.To carried out the marketed/Innovator product characterization.Selection of Excipients based on Innovator product and finalised the Concentration range based on innovator product profile and recommended Concentration given in IIG/Drug & Excipients book or by applying the concept of reverse engineering.Optimization of Formulation Composition and Process with the concepts of Design of experiments.Selection of Dissolution medium based on solubility study and from literature survey i.e. Orange book.Carried out Dissolution profile matching (F1-Dissimilarity factor & F2-Similarity factor) through adopting different Formulation and Process strategies.Performed Stability studies of new developed product as per ICH guidelines.Selection of Primary/Secondary packaging material based on innovator product and literature study.Responsible for documentation: Preparation of Product development report, technology transfer documements & Master formula record prior to submission.Execution of process validation batches and delivering departmental administration services. Show less
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As A Executive Formulation ScientistVovantis Lab Pvt Ltd. Sep 2014 - Dec 2014Ranoli, BarodaFormulation and Development of solid oral dosage forms (Tablet):Effervescent Tablets/Multivitamin sachets formulation (ROW)Provide technical input of query raised from regaff with respect to country.Patent search for desired Formulation and Development with WIPO, USPTO, Patent lens, Free Patents on line, Patent storms, Google patents.To perform Preformulation Study for the development of new drug products and interpretation of DSC and FTIR data. For Active pharmaceutical… Show more Formulation and Development of solid oral dosage forms (Tablet):Effervescent Tablets/Multivitamin sachets formulation (ROW)Provide technical input of query raised from regaff with respect to country.Patent search for desired Formulation and Development with WIPO, USPTO, Patent lens, Free Patents on line, Patent storms, Google patents.To perform Preformulation Study for the development of new drug products and interpretation of DSC and FTIR data. For Active pharmaceutical ingredients- check it physical, chemical & Biological properties.To carried out the marketed/Innovator product characterization.Selection of Excipients based on Innovator product and finalised the Concentration range based on innovator product profile and recommended Concentration given in IIG/Drug & Excipients book or by applying the concept of reverse engineering.Optimization of Formulation Composition and Process with the concepts of Design of experiments.Selection of Dissolution medium based on solubility study and from literature survey i.e. Orange book.Carried out Dissolution profile matching (F1-Dissimilarity factor & F2-Similarity factor) through adopting different Formulation and Process strategies.Performed Stability studies of new developed product as per ICH guidelines.Selection of Primary/Secondary packaging material based on innovator product and literature study.Responsible for documentation: Preparation of Product development report, technology transfer documements & Master formula record prior to submission.Execution of process validation batches and delivering departmental administration services. Show less
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Unique Pharma Lab JbcplJ.B.C.P.L Oct 2010 - Sep 2014Ankleshwar, Panoli Formulation and Development of solid oral dosage forms (Tablet): Immediate release (Tablets) and Modified Release Tablets (Sustained release and Delayed release formulation for Domestic & Regulated markets. Development of taste masked products for pediatric patient for domestic market Using different resins grade. I.e. Mouth dispersible tablet. Literature search for development of new products. Patent search for desired Formulation and Development with WIPO, USPTO, Free Patents… Show more Formulation and Development of solid oral dosage forms (Tablet): Immediate release (Tablets) and Modified Release Tablets (Sustained release and Delayed release formulation for Domestic & Regulated markets. Development of taste masked products for pediatric patient for domestic market Using different resins grade. I.e. Mouth dispersible tablet. Literature search for development of new products. Patent search for desired Formulation and Development with WIPO, USPTO, Free Patents on line, Patent storms, Google patents. To perform Preformulation Study for the development of new drug products and interpretation of DSC and FTIR data. For Active pharmaceutical ingredients- check it physical, chemical & Biological properties. To carried out the marketed/Innovator product characterization. Selection of Excipients based on Innovator product and finalised the Concentration range based on innovator product profile and recommended Concentration given in IIG/Drug & Excipients book. Optimization of Formulation Composition and Process with the concepts of Design of experiments. Selection of Dissolution medium based on solubility study and from literature study.i.e Orange book. Carried out Dissolution profile matching (F1-Dissimilarity factor & F2-Similarity factor) through adopting different Formulation and Process strategies. Performed Stability studies of new developed product as per ICH guidelines. Provide the sample for Bio-study and Interpretation/comparision of Bio-study data with innovator product. Selection of Primary/Secondary packaging material based on innovator product and literature study. Review of product documents prior to dossier submissions. Responsible for documentation: PDR, TT documements & MFR prior to submission. Execution of process validation batches and delivering departmental administration services. Co-Ordination of development activities within R&D, QA, ADL and Production. Show less
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Formulation ScientistJ.B.C.P.L Oct 2010 - Sep 2014
Axaykumar Patel Skills
Axaykumar Patel Education Details
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Net Pharamcay College, Post GraduationDistinction -
R.C.P College Of PharmacyDistinction
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S.V.E.M School
Frequently Asked Questions about Axaykumar Patel
What is Axaykumar Patel's role at the current company?
Axaykumar Patel's current role is Deputy manager | Pharmaceutical development | QBD concept| IVIVC| working for regulatory market i.e. EU & US| ROW market| Project Management|.
What schools did Axaykumar Patel attend?
Axaykumar Patel attended Net Pharamcay College, Post Graduation, R.c.p College Of Pharmacy, S.v.e.m School.
What skills is Axaykumar Patel known for?
Axaykumar Patel has skills like Drug Delivery, Differential Scanning Calorimetry, V&v, Ich Guidelines, Technology Transfer, Validation, R&d, Designing Formulation With Current Updated And Research Technology, Hplc, Pharmaceutical Research, Dissolution, Quality By Design.
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