Pharma Science and Research

A Better Tomorrow Starts Today

Pharma Science and Research

A better tomorrow starts today

Pharma Science and Research

A better tomorrow starts today

About Us

Pharma Science and Research (PSR) was established in August 2017 with a vision to provide cost effective, innovative, scientific solutions for the pharmaceutical and biotechnology sectors. To archive this vision, PSR has set up a team of professionals with extensive experience in the global pharmaceutical industry. PSR currently operates two research and development facilities. Our research and development facility operates out of the heart of Auckland city, located at 36 Copsey Place, Avondale. From this facility, our highly experience scientific and project management teams ensure that all development projects undertaken are executed in a timely, quality focused, cost effective manner while maintaining customer confidentiality and the protection of all intellectual property under development.

PSR has a strong focus on client satisfaction, safety, ethics and integrity. Our ability to deliver significant value to our customers by leveraging our scientific skills and global mind set is at the core of all project work undertaken for our customers.

Our Services

PSR aid in your research and development activities from any stage during the product development process. With thorough pre-formulation assessments ,stable ,scalable, robust and efficient technology transfer processes, our team can efficiently move your molecule along the product development pathway. We support our customers with services across the product lifecycle and each service can be offered as either as a standalone option or in conjunction with other services across the product life.

 

Development for NCEs

We offer a broad range of services for NCE development. The formulation could be a simple API in capsule or may require a drug delivery system to be developed. PSR has necessary expertise and access to advanced technologies to develop the formulation and also, through the...
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Associate services

PSR has network of business associates that complements our provided services In order to facilitate client’s efficiency and productivity PSR can identify and work with its partners to provide following complementary services to you product development needs: API developm...
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Technology transfer

PSR has capabilities and experts to allow the performance of technology transfer tasks to various global manufacturing sites for the purposes of scale up and commercializing various products forms. PSR is capable of providing seamless transfer of technology of developed p...
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Formulation Development

At PSR our team of experts starts the development process by an extensive patent landscape followed by Quality-By-Design (QbD) tools throughout all stages of development process. Design of Experiments (DOE) along with risk assessment strategies i.e. FMEA allows us to desi...
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Pre-Formulation Services

Pre-formulation activities are one of the most crucial areas of the product development process.  These activities determine which process and delivery methods will provide the most stable form of the drug.  Our scientists evaluate the chemical and physical properties of ...
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Stability Studies

At PSR we have a dedicated group of qualified personnel to conduct stability studies of drug products and substances in compliance with ICH guidelines. We have reach-in stability chambers including refrigerated and freeze thaw conditions as well as photo stability and an ...
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Analytical development and validation

PSR’s analytical team offers a range of standalone services and also supports our formulation development activities. The analytical teams are integrated with pre-formulation, product development and quality assurance teams to ensure effective and accelerated product deve...
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Our Team

At the nucleus of the PSR NZ team is comprised of experienced formulation and development staff with vast industry based experience.  PSR NZ Formulation and Development Scientists are experts in the fields of formulation and production theories and modern analytical science techniques.

Akhil Jain

Akhil Jain

Chief Executive Officer

As PSR NZ Chief Executive Officer, Akhil Jain has spent the last 10 years working the within the senior management team of a leading regulatory pharmaceutical company, ELC group as their vice president of Strategic Alliances and Business Development. With ELC group, Akhil headed ELC groups’ global marketing strategies, working with pharmaceutical clients across all EU states, EEA, CIS, MENA, China, Taiwan, India and South East Asia on providing a unique end to end solution to clients from offering attractive product portfolio to bringing them on to target markets. and expansion of ELC groups’ business through the initiation of new start up entities

Akhila Raman

Akhila Raman

Vice President of Regulatory Affairs

Akhila has joined Pharma Science and Research Limited after spending the last 20 years working in the field of pharmaceutical regulatory affairs. Akhila’s work experience in the regulatory affairs field has spanned from the dossier submission process for both Active Pharmaceutical Ingredients (API) and Finished Dosage forms for numerous therapeutic segments.

Akhila specialises in two areas:

  • The taking of newly developed or existing products through regulatory process to allow our clients to gain access to all major global markets including: Asia, Latin America, CIS, Middle East, South Africa, Canada, Australia, Turkey. Akhila has also performed extensive work across the European Union with major European regulatory agencies including the EMA, MHRA, BfArM, EDQM covering all licensing procedures and application types.
  • The supporting of strategic regulatory activities impacting core business strategies (from identifying and targeting products to assist in increasing a client’s profitability and profile, to life cycle management and managing dossier submission of the API and Finished Dosage forms and the performance of GMP Audits on manufacturing facilities).
Ajit K. Shinde

Ajit K. Shinde

Director of Formulation Studies

Ajit K. Shinde comes to Pharma Science and Research with 15 years of experience in developing the drug products for US, Europe, Brazil, Canada, Australia and WHO-PEPFAR markets. During this period, Ajit has succeeded in having

  • 20 oral solid dosage products approved for use in U.S. Pharmaceutical markets
  • 15 oral solid dosage product filed for use in European Pharmaceutical markets

Beginning his career with Cipla Ltd, as a Research Officer, Ajit has held numerous technical positions throughout the pharmaceutical industry reaching the position of Senior Principle Scientist with Prerrigo before joining Pharma Science and Research Limited. Ajit has an extensive background and expertise in the following areas:

  • Design and development of Novel Drug Delivery systems such as Extended release dosage forms, Controlled and Delayed release dosage forms, preparation of oral liquids/solutions and Suspensions, many of which involved novel excipients with novel usage functions to overcome the patent limitations.

  • Interpretation of bioequivalence results along with formulation factors that affect the rate and extent of drug availability. This information is critical in improving scale-up of the drug product from laboratory to commercial scale.

  • Utilization of drug pharmacokinetics during drug product development to clear the fasting and fed state observed during the performance of bioequivalence studies.

  • Having extensive Patent and IPR evaluation knowledge, developing non-infringing drug formulations with the use of novel excipients or combination ratios to overcome the Bioavailability-bioequivalence or stability related issues of drug product.

Dinesh Y. Parsai

Dinesh Y. Parsai

Director of Formulation Studies

With 13 years of formulation expertise gained from working with a range of pharmaceutical companies. Beginning at Lupin Pharmaceuticals as a Research Associate, Dinesh Y. Parsai has held positions as a Formulation Specialist with Bilim Ilac Pharmaceuticals, Deputy Manager of Formulation Development at Ajanta Pharma Limited (Advent) to Formulation Manager with ELC-Group Research Pvt. Ltd.

Dinesh Y. Parsai has focussed on the formulation and development of generic medicines across multiple dosage forms for multiple world-wide pharmaceutical markets, including the U.S. and Europe. Dinesh specialises in process development allowing for the scale up of concepts from laboratory to commercial scale.

Dinesh is an industry expert in the following areas:

  • Designing of patent non-infringing formulation strategies.

  • Pre-formulation studies and stability studies as per ICH guidelines.

  • Formulation of bioequivalent solid oral dosage forms such as; immediate release, sustain and delayed release tablets, mouth dissolving and chewable tablets, capsules and dry powder suspensions using a QbD approach.

  • Co-ordination and resource planning for the development, technology transfer and manufacturing of pilot/pivotal batches for BE studies.

  • Interpretation of in-vivo bioequivalence study data for the comparable pharmacokinetic parameters.

  • Development of raw material, API and product specification (In-process, release, regulatory and shelf life specifications).

Venkataramana N.V

Venkataramana N.V

Director of Analytical Studies

As the director of analytical studies, Venkataramana N.V has over 12 years of experience in the field of project management, analytical method development and the conducting stability studies used for both product development and registration purposes pharmaceutical companies with such as, Strides Acrolab, SPI Pharma Inc. and Syngene International Pvt. Inc.

With an in-depth knowledge and understanding of pharmaceutical chemistry, Venkataramana N.V brings the following expertise to Pharma Science and Research Limited:

  • Management of large research and development projects in the field of pharmaceutical drug development.

  • Experimental design, method validation and troubleshooting for analytical methods devised for product characterisation, release and stability testing across a multitude of drug delivery forms, for example; Solid oral dosage forms, capsules, suspensions, liposomes, dermal/transdermal, Emulsions, depot therapy, ophthalmic and sterile injectables.

  • Expert in identifying and developing the correct methods for the reverse engineering of pharmaceutical products (Q1 and Q2 matching).

  • Extensive knowledge and experience in developing methods for the intrinsic dissolution testing (type III and IV) for API’s in solid oral dosage forms.

  • An in-depth knowledge and troubleshooting abilities with respect to all laboratory analysis techniques used in modern pharmaceutical laboratories.

Kushal Vyas

Kushal Vyas

Director of Intellectual Property

Kushal Vyas is the Director of Intellectual Property at Pharma Science and Research Limited. Specialising in pharmaceutical intellectual property and product portfolio management, Kushal has developed product specific strategies for key international markets, including preparing freedom to operate search reports, management of patent filings and prosecution and preparing patent validity challenge summaries. He has also closely worked with counsels for strategizing multiple Paragraph IV ANDA patent litigations.

Prior to joining Pharma Science and Research Limited, Kushal has worked for several pharmaceutical and pharmaceutical regulatory consulting companies such as Amenal Pharmaceuticals, Alembic Pharmaceuticals and ELC group.

Praveen C. Surana

Praveen C. Surana

Senior Director of Business Development

Praveen C. Surana is a trained pharmacist with in graduate diploma management. He comes on board with more than two decades of experience in Global and Indian Pharmaceutical Industry. During his career, Praveen has held positions ranging from the head business development with P&L responsible for Global CDMOs and has handled various marketing teams for pharmaceutical companies in the Indian market. Praveen is equipped with proven abilities in the areas of devising corporate strategies to augment global business of a contract research organisation such as PSR. His expertise ranges from Sales and marketing to P&L management for organisations and he also has experience of working in various therapeutic segments during his career.

Our Advantage

 

We believe, success of any outsourcing project requires:

  • Integrity, confidentiality and respect for IP
  • Streamlined and uninterrupted work flow
  • Strong interface between the client and service provider
  • Good understanding of regulatory environment
  • Appreciation of cultural complexities
  • Flexible business models

At PSR helps we adhere to our beliefs thus ensuring our clients gets more than our promise.

Our Facilities

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Contact Us


  • +64 9 8285817
  • https://www.psrnz.com
  • 36 Copsey Pl. Avondale
    Auckland , New Zealand