CRAMS

S. Zhaveri’ s experience of several years to promote Excipients with techno marketing, to Pharma industry, initiated us to start Contract Research Centre in the year 1999 in Mumbai. The Contract Research Centre caters for all kinds of dosage forms, solids, semi-solids, liquids, etc.to all Regulated Markets. The company then built a state of the art Low RH Contract Manufacturing Facility at Mumbai. Below are the details of the activities we do, at a glance.



FORMULATION DEVELOPMENT

We offer a range of pre-formulation and formulation development services on new active substances, generics and upgrades of existing formulations.

WE CAN :
 Develop standard dosage forms
  • Tablets, capsules, pellets 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 coated and enteric coated tablets, using either aqueous organic solvents

ANALYTICAL DEVELOPMENT

We provide analytical and documentation support for a wide variety of product development programs.

WE CAN :
  • Develop and validate methods
  • Establish potency of product within appropriate range
  • Establish degradation of product within recognized limits
  • Supply method transfer protocols
  • Conduct stability-indicating assays in accordance with specific protocols
  • Work according to ICH and cGMP 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
  • Statistical Analysis and Data Trending
  • Forced Degradation Studies
  • Photostability

DOSSIER COMPILATION

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

WE CAN :
  • Compilation of the dossiers according to CTD-format 1-5 including handling of deficiency letters
  • Compilation of e-CTD
  • Compilation of USANDA
  • Co-ordination of translations

CONTRACT MANUFACTURING

S. Zhaveri Pharmakem Pvt. Ltd. provides a state of the art EU GMP approved manufacturing facility designed to meet the international requirements of global regulatory bodies.

The facility provides flexibility & scalability in operations & can undertake manufacturing of different batch sizes. We have the capability to handle all the major therapeutic segments and can manufacture Oral Solid Dosage Forms: Tablets (Coated and Uncoated), Capsules, Granules & Powders.

We have the capability to supply small-scale clinical trial quantities and commercial-scale requirements. Our end-to-end services and competitive pricing offers a compelling value proposition to our global customers.

Highlights :
  • EU GMP Approved
  • EU Falsified Medicines Directive Serialisation compliant
  • Batches up to 500Kg scale
  • Unidirectional material flow
  • Adequate & Secured Storage facility
  • Separate personnel / material entry
  • Dedicated AHUs for each cubical following pressure cascade
  • Facility to handle products requiring RH below 20 %