Монтажная область 12

Pharmaceutical development

from research to production batches

Contact us
about-1.jpg
about-2.png
about-3.jpg

About us

CHEMEX is an Armenian research company.
It is aimed at developing long-term and mutually beneficial relationships with drug manufacturers.
An integrated approach to the implementation of pharmaceutical development.

Activities of CHEMEX

  • Pharmaceutical development of API and FPP

    Draft normative document
    Pharmaceutical development report

  • Technology Transfer of API and FPP

    Technology Transfer Report

  • Equipment selection

    URS and offer for the selected equipment

activities.jpg

Pharmaceutical development goals

Quality cannot be tested in a drug, quality must be built into the pharmaceutical development.

  • –°reation of a medicinal product of the required quality
  • Substantiation of the process of its production
  • Subsequent production of products with specified functional characteristics without deviations and the risk of complaints

Stages of pharmaceutical
development

  • Preliminary exploratory studies, development of API production technology
  • Preliminary exploratory studies, development of the composition and production technology of FPP
  • Development and validation of analysis methods
  • Dissolution kinetics research
  • Standardization of API and excipients
  • Stability study

Problems that pharmaceutical
companies face today

Time-to-market for a drug plays a critical role in the development of pharmaceutical companies

problems.jpg
  • icon-exclamation.svgThe need to search for and develop new drugs to expand the portfolio of manufactured drugs
  • icon-exclamation.svgHigh complexity and duration of pharmaceutical development
  • icon-exclamation.svgLack of resources for research and pharmaceutical development
  • icon-exclamation.svgHigh competition in the drug market

Our task is to carry out pharmaceutical development of a drug and lay the foundation for the quality of future products for subsequent stable production

Technological possibilities
in dosage forms

technological-1.jpg

Tablets

technological-2.jpg

Hard gelatin capsules

technological-3.jpg

Powders and granules

technological-5.jpg

Tablets used in oral cavity

for sucking, chewable orally dispersible, etc.

technological-4.jpg

Film-coated tablets

technological-6.png

Modified release tablets

enteric, with prolonged release, etc.

technological-7.jpg

Lyophilizates

Our advantages

  • Professional

    Qualified specialists with extensive experience in the field of pharmaceutical development and quality assessment, production and quality control of medicines

  • Modern

    Modern equipment that allows solving a wide range of analytical and technological problems

  • Helpful

    Assistance in the formation of the Registration Dossier in terms of production and analytics, responses to requests for drug registration

  • Affordable

    Reasonable deadlines and budget for projects of any complexity