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 Expert  726302

Expert in Formulation, Development and Manufacturing of Pharmaceutical Dosage Forms


Available for your Consulting and Expert Witness Needs

NSW
Australia
Education Work HistoryPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
Expert has extensive product development experience in solid dosage forms (TABLETS {IR & ER} , HARD & SOFT GELATIN CAPSULES AND POWDERS); Liquid dosage forms ( SOLUTIONS, SUSPENSIONS & EMULSIONS) from conception through to stability trail, clinical studies, validation; final manufacture, registration and release with many years in humans and veterinary pharmaceuticals. He had good experience in troubleshooting and process improvement.

Expert has extensive knowledge on developed and manufacturing of controlled release sold dosage forms including hydrophyllic and hydrophobic matrix systems and multiparticulate dosage forms. He has very good experience in development of softgel or soft gelatin capsules & hard gelatin capsules and experienced in solving all kinds of ongoing production problems. He has extensive knowledge on development and manufacture of all kinds of softgel gels like enteric coated, controlled relaese and concentional neutraceutical softgel products.

He is experienced in the development of Immediate release and Exended release solid dosage forms and he has very good experience in technology transfer and technical support to solve ongoing production problems. In addition to developing several prescription drug products, he has extensive experience in the development of OTC products. He has produced both controlled release as well as immediate release hormone, anti cancer, antibiotic, steroid, cough and cold, oral care, systemic and topical products for both OTC and professional marketing.

He has vast knowlege on development of all kinds of controlled release like matrix type, microencapsulation; osmotic, flotable; microballone systems and make it commercilase. Expert has very good experience in development and manufacturing of all knds of liquid dosage forms like solutions, suspensions and emulsions. He has good knowledge on development of all kinds of sustanined release forms. He has vast knowledge on improvement the bioavailability of poorly soluble drugs at the commercial level.

He has good knowledge in hard gelatin cpsules development, technology transfer and trouble shooting. He has good knowledge on development of solid, liquid and semisolid dosage forms, from development, technology transfer and trouble shooting. He has good knowledge on all kinds of OTC products development. He worked on number of molecules to develop parenteral products. He has very good experience on all kinds of oral drug delivery systems. Expert 's experienced in development and manufactur of all kinds of softgel capsules.

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contract manufacturing

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controlled-release drug delivery

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gelatin capsule

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tablet manufacturing

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controlled-release oral drug delivery

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pharmaceutical liquid

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drug delivery

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pharmaceutical capsule

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drug dosage form development

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over-the-counter drug product development

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injectable pharmaceutical product

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oral drug delivery

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parenteral drug delivery

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pharmaceutical drug

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pharmaceutics

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solid pharmaceutical product

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drug formulation

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softgel capsule


Show Secondary and Basic Areas of Expertise

Often requested
with this expert:

Pharmaceutical Manufacturing, Research and Development,...
Pharmaceutical Solid Dose Forms
Chemistry R&D and cGMP Manufacturing, Pharmaceutical...
Drug Delivery, Formulation Development of NCE's,...

Education:
Year   Degree   Subject   Institution  
2002   Ph.D   Pharmaceutical technology   Andhra University, India  
1995   M.Pharm   Pharmaceutical Technology   Andhra University, India  
1993   B. Pharm   Pharmaceutical Sicences   Andhra University, India  

Work History:
Years   Employer   Department   Title   Responsibilities

2010 to

 

Expert's Firm

 

Research and Development

 

Head - Research and Development

 

1. Leading highly motivated and target oriented team of scientists for product development and coordinates with Regulatory, Quality Assurance, Marketing and Manufacturing departments. 2. Responsible for develop various kinds of dosage forms like TABLETS (IR & ER), capsule (HARD & SOFTGEL), LIQUIDS; CREAMS/OINTMENTS from conception through stability trial, clinical studies, validation, final manufacture, registration and release for non-regulated and regulated markets like TGA, MEDSAFE & US-FDA etc 3. Technical Support to production

2005 to 2010

 

LIPA Pharmaceuticals Australia

 

Research and development

 

Snr. Principal R&D Scientist

 

1. Development of generic products for US companies like ENDO Pharmaceuticals; IMPAX ect. 2. Responsible for develop various kinds of dosage forms like TABLETS (IR & ER), capsule (HARD & SOFTGEL), LIQUIDS; CREAMS/OINTMENTS from conception through stability trial, clinical studies, validation, final manufacture, registration and release for non-regulated and regulated markets like TGA, MEDSAFE & US-FDA etc 3. Technical Support to production 4. Lead the R&D group and coordinates with Regulatory, Clinical, Marketing and Manufacturing teams.

2002 to 2005

 

Ancare NZ Limited

 

Research and Development

 

R&D Scientist

 

Developed Veternary products for USA, Australia and New Zealand Markets 2. Project planning, development and management disciplines and reporting 3. Developed new technologies for kept incompatible drugs in single unit dosage forms and patent. 5. Development of bioequivalent generic products to seek USFDA approval. 6. Involved in many cost reduction projects, which are on going production batches. 7. Solved some of the problems, which occurred in on going production batches in injectables, liquids and semi solid dosage forms.

2002 to 2003

 

University of Auckland, Auckland, NEW ZEALAND

 

School of Pharmacy

 

Honorary Research Fellow

 

1. Given the support to establish the newly established School of Pharmacy Deportment. Developed lipid based drug deliver systems for poorly soluble systems. 2. Evaluated the new excipient for controlled release dosage form and applied for the patent. 3. Performing research and development, which is aimed at presenting solutions to NZ companies incorporating recent advances in science and technology.

2001 to 2002

 

Cadila Pharmaceutical Ltd, Ahmedabad, INDIA

 

Formulation Development Devision

 

Research & Development Executive

 

1. Development of bioequivalent ANDA products to seek USFDA approval under Para 1, 2, 3 & 4 filing. 2. Developed delayed release formulation for rifampicin. 3. Prepared oral dosage forms like tablets, liquids, injectables and ointments. 4. Involved in many cost reduction projects, which are on going in production. 5. Solved some of the problems, which occurred in ongoing production batches.

2001 to 2001

 

Ajanta Pharma Ltd, Mumbai, INDIA

 

Formulation Development Division

 

Research & Development Executive

 

1. Developed floatable drug delivery systems for ciprofloxacin, amoxycillin. 2. Handled various granulation techniques (Aqueous, Nonaqueous and melt) for oral controlled and immediate release products. Prepared oral dosage forms like, tablets, capsules, liquids, and ointments. 3. Involved in many cost reduction projects, which are ongoing in production. 4. Solved some of the problems, which occurred in ongoing production batches.

1996 to 1998

 

NET Pharmacy College, Raichur, INDIA

 


 

Lecturer

 

1. Taught a group of Pharmaceutics subjects to undergraduate students. 2. Consultation to the pharmaceutical companies.


Publications:
Publications and Patents Summary

He has 25 research paper published in rupeated journals and 7 poster presentations. He owns two patents on delivery systems

Selected Publications and Publishers  
 - International Journal of Pharmaceutics  
 - Drug Dev. Ind. Pharm  
 - PCT=patent  
 - INDIAN PATENT OFFICE  

Consulting Services:
Recent Client Requests:
  • Expert oral dosage pharmaceutical tablet formulation excipient compatibility API degradation pathways phase III trials CMC pharmaceutical formulation development expert for consulting on oral dosage tablet formulation development.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
2005 to   AUSTRALIA   Development of various types of dosage forms from conception through to stability trail, clinical studies, validation; final manufacture, registration and release with many years in humans and veterinary pharmaceuticals for non-regulated and regulated markets like TGA, MEDSAFE and US-FDA etc. His expertises include supervision of R&D team and coordination with Marketing, regulatory affairs, clinical, Quality assurance and production departments and he has very good knowledge in formulation improvement and process quality improvement. He has much knowledge on different kinds of dosage forms like SOLID DOSAGE FORMS (TABLETS, HARD & SOFT GELATIN CAPSULES), INJECTABLES, OINTMENTS/ CREAMS, TRANS DERMAL DRUG DELIVER SYSTEMS AND LIQUID DOSAGE FORMS. Expertise on development of NDDS products and many years of experience in PATENT writing and analysis.
2002 to 2005   NEW ZEALAND   Development of Various kinds of dosage forms in veternary pharmaceuticals.

Language Skills:
Foreign Language   Description
English   He has high level of proficiency in writting and spoken technical english

Market Research:
In-depth knowledge on manufacturing facility setup / R&D facility setup & product development and technical support on softgel capsules; solid dosage forms, liquid dosage forms and semisolid dosage forms.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Training/Seminars

Provide training /seminars on cGMP; product development and regulatory requirements for USFDA; UK-MHRA and TGA.


 

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