Contract Research Center

Contract Research Center (CRO - Pharmaceutical Formulation Development)

S. Zhaveri Pharmakem Pvt. Ltd. SZPPL is an integrated pharmaceutical RESEARCH and DEVELOPMENT company delivering wide range of products for the generic industry. It aims to be a leading provider of fully integrated and cost effective pharmaceutical out-sourcing services to the international healthcare industry.

The R&D is not only equipped with sophisticated instruments but also manned by highly skilled and experienced professionals. The company has a close co-ordination with International companies for providing prompt and quality services.

We provide flexible pharmaceutical solutions enabling our customers to accelerate their route to market quickly, safely and cost efficiently.

We differentiate our capabilities from competitor companies by maintaining a flexible, personal and responsive service to satisfy individual customer requirements.

  • State of the art facility designed to meet the requirement of USFDA and EU specifications
  • 26000 Sq. ft. of area for Research & Development for finished formulations
  • Low Humidity Areas to handle specific products
  • Wide range of GMP machines to handle different technologies
  • Qualified team of doctorates, Masters in Pharmaceuticals and Bachelors Pharmaceuticals

SZPPL is in a position to offer the following broad spectrum of services
  • Formulation Development
  • Analytical Development
  • Stability Studies
  • Dossier Compilation
  • Therapy Areas

Formulation Development
We offer a range of pre-formulation and formulation development services on new active substances, generics and upgrades of existing formulations. From pilot batches for stability testing and validations; providing technology transfer and from development support for scale-up to commercial production. Our expertise ensures a high level of support throughout the early stage of product development, our project teams working closely with our clients to establish optimal formulations.

We Can :
  • Produce standard dosage forms
    • Tablets, capsules and powders
    • Oral liquids, solutions, suspensions and emulsions
    • Granules for reconstitution
  • Work with modern and novel dosage forms and delivery systems
    • Controlled release
    • Sustained release
  • Film coating and enteric coating tablets, using either aqueous or organic solvents
  • Produce pilot batches for stability and validation
  • Produce standard dosage forms

Analytical Development
We provide analytical and documentation support for a wide variety of product development programmes. With an extensive range of fully validated analytical options available, as well as comprehensive stability studies expertise, we work closely with our clients to assist at every stage of the product development cycle. We will apply our expertise and understanding of all relevant regulatory requirements to ensure that your development programmes are implemented professionally and accurately. Our competence in this specialist area provides you with the benefit of the data and documentation necessary for product accreditation.

We Can :
  • Develop and validate methodologies.
  • Establish potency of product within appropriate range.
  • Establish degradation of product within recognized limits.
  • Eliminate errors / optimize success from the start.
  • Provide accurate analytical data to support formulations.
  • Supply method transfer protocols.
  • Conduct stability-indicating assays in accordance with specific protocols.
  • Work according to ICH and c GMP guidelines.
  • Provide expert documentation for regulatory submission worldwide.

Stability Studies
We provide stability testing for all types of commercial and pre-market drug products. We offer standard storage conditions, meeting ICH guidelines, along with any specialized storage conditions your product may require. Each stability chamber operates independently with its own temperature and humidity controls. All storage chambers are continuously monitored, and failures outside set point ranges result in an immediate alert to the stability staff. Additionally, all of our storage chambers are on full generator backup in case of power failure.

We Can :
  • Provide Protocol Design
  • Long-Term Stability Testing
  • Accelerated Stability Testing
  • Commercial Product Stability Testing
  • Comparator Stability Testing
  • Formulation Evaluation Stability Testing
  • Statistical Analysis and Data Trending
  • Forced Degradation Studies
  • Photo stability
  • Temperature Cycling

Dossier Compilation
We compile dossier according to the requirements of the regulatory authority and the markets.

We Can :
  • Compilation of the dossier according CTD-format 1-5 including handling of deficiency letters.
  • Compilation of e-CTD
  • Compilation of US NDA
  • Co-ordination of translations
  • Co-ordination of clinical and pharmacological-toxicological expert reports
  • Co-ordination of clinical studies for bioavailability and compatibility

Therapy Areas
SZPPL caters to a wide therapy areas covering
  • Cardiovascular
  • Central Nervous System (CNS)
  • Dermatological
  • Gastrointestinal
  • Genito-urinary
  • Infectious Diseases .
  • Respiratory, etc