Development & Support
 
 

  • Pharmaceuticals
     
  • Medical devices
     
  • Cosmetics
     
  • High Added Value Nutritionals
     
    We offer solutions and fast assistance
    with
       
  • Registration issues
     
  • Notification of defects
     
  • Analytical issues
     
  • Preformulation studies
     
  • Stability tests
     
  • Production transfer
     
  • Technical filing of quality dossiers
You require customized analytics for testing of pilot batches?
  
We develop specifications and specific methods including validation in compliance with the valid ICH requirements. Further to an appropriate laboratory equipment including fluorescence measurement, GC and HPLC with UV, DAD and
ELS-Detection we are proud to present our new microbiological laboratory.
 
You require support for stability issues ?
  
We carry out stability studies for active ingredients and finished products, with storing the samples in compliance with ICH requirements and analytical testing, validation and reporting according to your request. In case of OOS- incidents we ensure immediately information and consultation regarding the further proceeding.
 
You require a technical file or registration dossier prior to launch your product?
  
Attuned to your targets we will develop a registration strategy. Our consultation is based on the current state of regulations and will cover all technical issues. We draw up dossiers of all appropriate formats, i.e. CTD, and assist you regarding the treatment of notification of defects.
 
This is what we can do for you!
 
You have got the idea for a new product?
 
We plan, develop and implement a customized galenic solution, e.g. manufacture of lab and pilot batches or feasibility batches. We adapt flavour, taste, colour as well as other product properties and carry out pilot batches for market surveys.
 
 
You like to give go-ahead for production?
  
We develop a functional, practical and appealing packaging for your product and carry out compatibility studies. The production of pilot batches and the scaling-up to production size is easy to handle in our GMP-certified plant.
 
How can we support you?
 
You are welcome to discuss your ideas with our well experienced contact persons or agree upon the evaluation of your product sample. Of course we keep all provided background information, samples or evaluation results striktly confidential!
 
Your contact person:
Dr. Florentine Grunwald
Phone: +49(0)45 54 – 90 70-310
E-Mail: fgrunwald@lichtenheldt.de
 
 
Development, Manufacture, Filling, Packaging, Storage, Shipping.
 ... competence in all areas.
 
That's full service ...
           ... thats's LICHTENHELDT
 

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