CORE EXPERTISE

Product Development

Product Development


Astral SteriTech is well equipped to manage our client’s entire project from pre-formulation and formulation, to pilot scale and commercial production.

Our project management team, which has extensive experience in various areas of the pharmaceutical industry, to advise our client on product development, and enhancement strategies, the manufacturing and control processes and the delivery of the product ready for sale. We are also happy to respond to their individual wishes, right up to customer-specific packaging material development and brand extension development.

Expertise and support at each phase of the drug program is available from development, analytical services, cGMP manufacturing and later stage development and commercialization. Our teams of experts offer following comprehensive solutions to streamline and expedite the development and manufacturing of powder injectables from the Cephalosporin and Penicillin classes.


  1. Study of active ingredients
  2. Formulation screening and development
  3. Development and validation of analytical methods for drug products, raw materials and cleaning methods
  4. Development and update of analytical methods for degradation products
  5. Technical transfer and validation
  6. Design, execute and analyze pre-stability / regulatory or commercial stability studies
  7. Thermal excursion studies
  8. Primary and secondary packaging identification and evaluation

SERVICES

  1. Study of active ingredients
  2. Formulation screening and development
  3. Development and validation of analytical methods for drug products, raw materials and cleaning methods
  4. Development and update of analytical methods for degradation products
  5. Technical transfer and validation
  6. Design, execute and analyze pre-stability / regulatory or commercial stability studies
  7. Thermal excursion studies
  8. Primary and secondary packaging identification and evaluation