Pharmaceutical Product Development Analytical Method Validation, Formulation Development

Getz Pharma Research, a contract research organization

, is committed to provide Pharmaceutical products and Services of highest Quality standards through continual improvement and in compliance with the applicable regulatory requirements in ways that maximize efficiency, save resources and increase customer satisfaction. Getz Pharma continuously improves its processes for dosage form development, and always delivers reliable quality in their products and services. All the systems are supported with detailed standard operating procedures and specific protocols, which are authorized for use by Quality Assurance.

Getz Pharma Research, a pharmaceutical product development firm, initiates each drug development program with major consideration for implementing the most effective regulatory strategy. All the strategies are planned to cost-effectively achieve near and long-term goals. We believe potential issues addressed early will accelerate overall development time. GPR offers customers a fully integrated and seamless dosage formulation development program generally includes API characterization, patent landscaping, pre-formulation studies, excipient- compatibility studies, product-pack integrity studies, analytical methods validation and development, development of non-infringing formulation, composition and process optimization, stability studies, scale-up and process validation, manufacture of registration/ submission batches, assist client in preparation of the ICH Module P3 / Chemistry, Manufacturing and Controls (CMC) section and SUPAC support.

Getz Pharma Research is committed to the safety and health of its employees and visitors and care of the environment and the prevention of accidents, health hazards and pollution. The Company ensures that all the activities and services carried out and products are manufactured under appropriate Environmental, Health and Safety risks, aspects, impacts and objectives and in conformance with the relevant legal requirements.

EHS Objectives

* Identify and update systems for the safety, health & environmental hazards and risks associated with our activities and products

* To improve conditions in order to prevent accidents, health hazards and pollution

* To minimize waste generation, promote recycling and green chemistry

* To reduce energy consumption

* To promote safety awareness among our customers

Owing to the nature of Getz Pharma Researchs business, it receives and generates confidential client related information. In order to protect the confidentiality & integrity of the client, all the scientist working on site are required to sign a CDA with the company. All R&D engagements are governed by a written agreement between client and Getz Pharma Research as well as and its employees, consultants and associates.

by: Radhika Acharya

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