Expert Details
Formulation Development
ID: 731345
India
Expert obtains and reviews all available public information about the innovator or “reference” product i.e. PDR, CPS, Merck Index, product labels and inserts, published literature in pharmaceutical and medical journals, patents etc. Experienced in the pre-formulation, formulation and process development, clinical supplies formulation for NCE and generic products and scale up of immediate release tablets (Including low dose), delayed release, extended release tablets, film coated, sugar coated, Bilayer tablets, soft and hard gelatin capsules, oral liquids, Lozenges, suspensions, chewing gums and parenterals/ophthalmic formulations.
Expert used Biopharmaceutical Classification System and Pharmacokinetic parameters in relation to selection of Discriminating Dissolution method, Release dissolution methods for solid dosage forms design.
He is very familiar with various monographs and general chapters of USP/NF, EP, other compendium and industry standards.
He is experienced in supporting plant documentation, revalidation, Quality & productivity improvement & technical trouble shooting. Expert has coordinated with Regulatory, Production, QA and QC for New product launch with Validation, revalidation and Technology Transfer activities; supported to regulatory for filing & Regulatory queries, providing registration samples.
Expert is well versed in generation, maintenance and revision of SOPs, specifications, procedures, batch records, training, OOS investigations, and other documentation systems; Wide exposure to quality assurance, manufacturing, validation, compliance and regulatory areas in a pharmaceutical manufacturing environment; Proficient with common computer software. Excellent interpersonal, communication, managerial and organization skills.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1990 | Degree: M.Pharmacy | Subject: Drug Formulation and Technology (Pharmaceutics) | Institution: University College of Pharmaceutical Sciences, Kakatiya University, Warangal, Andhra Prades, India |
| Year: 1980 | Degree: B.Pharmacy | Subject: Pharmaceutical Sciences | Institution: University College of Pharmaceutical Sciences, Kakatiya University, Warangal, Andhra Prades, India |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2019 to Present | Employer: Undisclosed | Title: Consultant | Department: Pharmaceutical FDF |
Responsibilities:All FDF activities as received from clients |
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| Years | Employer | Title | Department |
| Years: 2015 to 2019 | Employer: Swiss Garnier Life Sciences | Title: General Manager | Department: R&D |
Responsibilities:Overall deliverables of formulations and technology transfer |
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| Years | Employer | Title | Department |
| Years: 2014 to 2015 | Employer: Acme Formulations Pvt Ltd | Title: General Manager | Department: FR&D |
Responsibilities:Overall deliverables of formulations and technology transfer |
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| Years | Employer | Title | Department |
| Years: 2010 to 2013 | Employer: Suven Life Sciences Ltd | Title: Senior Manager | Department: R&D (Formulation Development) |
Responsibilities:1. Directed all activities of the formulation development and technology transfer departments.2. Responsible for all activities of Formulation Development Department to ensure the delivery of products as per times lines of clients and company, compendia and regulatory requirements including the Quality by design and ICH Q8R2 norms for regulatory markets such as US, Europe, Brazil and Turkey. 3.Directly responsible for all activities of formulation development department with staff of over 10 people. 4. Delivered the formulations pellets, immediate release, modified release monolithic and bilayer tablets in the therapeutic areas of ant diabetic, Lipid lowering, cardiovascular, Proton pump inhibitors, and Antipsychotic drugs. 5. Successful Pilot Bio study for 5 solid oral dosage forms and one successful Pivotal biostudy. 6. Responsible for documentation review and approval of experiments in LNBs, analytical results, MFRs, specifications, and procedures and stability data review of developed products, Product development reports. |
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| Years | Employer | Title | Department |
| Years: 2010 to 2010 | Employer: Acme Formulations Pvt Ltd | Title: Head-Formulation Development | Department: Formulation Development |
Responsibilities:1. Successfully delivered the formulation development, technology transfer of various therapeutic categories of tablet and capsule formulations.2. Documentation responsibilities included Preparation MFRs, specifications, and procedures and stability data review of new and existing products. 3. Supported manufacturing, pharmaceutical technology and compliance departments in investigations, process validations, deviations. |
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| Years | Employer | Title | Department |
| Years: 2009 to 2010 | Employer: Promed Reseach Center | Title: Group Leader (Formulation Development) | Department: Product Development |
Responsibilities:1. Responsible for development, optimization, technology transfer and exhibit batches manufacturing of ophthalmic formulations for regulated markets (US and Europe) and Russian markets and delivered optimized formulae and process for two ophthalmic formulations.2. Responsible for documentation review and approval of experiments in LNBs, analytical results, MFRs, specifications, and procedures and stability data review of developed products, Product development reports. 3. Managed a staff of 5 people. 4. Undergone professional development programs: ANDA development guidelines conducted by Pharma Profiles. IPC 61 for the year 2009 at Ahmadabad, India. Quality by Design workshop conducted by International Business Conferences. |
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| Years | Employer | Title | Department |
| Years: 2006 to 2009 | Employer: Unichem Ltd | Title: Research Scientist II-Formulation Development | Department: R&D |
Responsibilities:1. Duties involved are responsible for development, optimization, technology transfer and exhibit batches manufacturing of solid orals and completed at various stages of development within timelines for following products for the Europe, US (ANDA) and Brazil Markets while guiding the Research Associates and Trainees in the therapeutic categories of CNS, Cardiovascular category drugs.2. Successfully developed bio equivalent products of ant migraine Orodispersible and film coated tablets. |
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| Years | Employer | Title | Department |
| Years: 2002 to 2005 | Employer: Banner Pharmacaps (I) Pvt Ltd | Title: Assistant Manager-Formulation Development | Department: Product Development |
Responsibilities:1. Developed, optimization, technology transfer and exhibit batches manufacturing completed for Soft gelatin capsule products for the clients like Novartis, Nicholas, Elder, Semit, UML (Dual release-SR & IR Day N Nite SR Soflets) and RPG Life Sciences etc. Regulatory dossiers prepared for the same.2. Product developed for Regulated Markets: i. Successful developed and commercialized Alfacalcidol Soft gelatin Capsules for South Africa and semi regulated Markets ii. Cyclosporine Soft gelatin Capsules Data submission to US affiliate |
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| Years | Employer | Title | Department |
| Years: 1999 to 2001 | Employer: Strides Arcolab Ltd | Title: Assistant Manager-Formulation Development | Department: Formulation Development |
Responsibilities:1. Successfully contributed in trouble shooting activities of solid oral dosage forms and Parenterals for anti TB, other antibacterial and antibiotic categories by reformulating and defining the better processes.2. Supported the regulatory affairs department in the preparation of MFRs of tablets, Hard and soft gelatin capsules and small volume parenterals dosage forms. 3. Supported manufacturing, pharmaceutical technology and compliance departments in investigations, process validations, deviations. |
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| Years | Employer | Title | Department |
| Years: 1996 to 1999 | Employer: Parke-Davis (I) Ltd | Title: Product Development Officer | Department: Product Development |
Responsibilities:1. Developed and Technology Transfer completed for dosage forms Phenytoin sodium caps 25 mg hard capsules & Phenazopyridine HCl Tablets100 mg, Abdec forte drops, Diltiazem HCl dual release tablets, Lozenges and chewing gums.2. Monitored the stability studies of developmental and initial production batches. 3. Studied the suitability of alternate source raw materials and their stability study-Mefenamic Acid, Benadryl cough formula, Abdec drops. 4. Cost improved by reformulating of existing product. |
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| Years | Employer | Title | Department |
| Years: 1990 to 1996 | Employer: TTK PHARMA LTD | Title: Junior Executive-Formulation Development | Department: R&D |
Responsibilities:Performed the formulations development, technology transfer and preparations of dossiers for Solid Oral Dosage forms for human and veterinary use for therapeutic categories of semi Synthetic penicillin, Calcium supplements and anti hypertensive drug products. |
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Government Experience
| Years | Agency | Role | Description |
|---|---|---|---|
| Years: 1985 to 1988 | Agency: Government Junior College, Parkal, Warangal, AP, INDIA | Role: Assistant Lecturer in Pharmacy | Description: Responsible for the departmental activities in completion of syllabus, conduction admissions and exams. Evaluating the students for their performance. |
Career Accomplishments
| Awards / Recognition |
|---|
| Received the Junior Research Fellowship by UGC-GATE for M.PHARM. |
| Publications and Patents Summary |
|---|
| 1. Submitted a thesis on Chemical Investigation of the Fruits of Terminalia Chebula as M.Pharm project. It was published in International Journal of Pharmacognosy. 2. Submitted as poster 'Evaluation of Dual Release Drug Delivery System as Gelatin coated Tablets (Soflets) for the Pharmaceutics and Drug Delivery (PDD) section. |
Additional Experience
| Training / Seminars |
|---|
| Expert can provide seminars on pharmaceutical development |
| Vendor Selection |
|---|
| Expert can be a source for vendors and suppliers for drug substances, Excipients, machinery and ancillary equipment, tooling for tablets, capsules etc. |