• Regulatory services
  • Product development

Product development

Die effiziente Entwicklung neuer Produktformulierungen erfordert bereits früh eine weitgehende Kenntnis von regulatorischen und GMP-Anforderungen

We will work with you to develop this strategy for your candidates and will accompany you through the preclinical and clinical development, right from the start. We will create the dossier for your clinical investigational medicinal product (IMPD, IND) and can even take care of all of the project management activities if you wish.

In addition, we offer you extensive analytical and technological services within the HWI group.

Our services:

Early development stage
  • Regulatory and strategic consulting
  • Implementation of the QM system and consultations on GxP aspects
  • Supplier audits
  • Comprehensive laboratory services (development and validation of analytical methods in order to determine structure, characterisation, identification, purity testing and assay)
  • Formulation development
  • Stability testing in accordance with ICH guidelines
  • Project management
Middle development stage
  • Development and validation of analytical methods in accordance with ICH
  • Method and technology transfer
  • Determining process- and product-related impurities
  • Analysis and evaluation of leachables and extractables
  • Monitoring and batch release by qualified persons (QPs) from HWI
  • ICH-compliant stability testing
  • Preparation of briefing books and coordination of scientific advice discussions with the authorities
  • Communication with the competent authorities
  • Coordination of our partners for preclinical and clinical development
  • Creation and submission of IMPDs and INDs for clinical trials
  • Manufacture, testing and release of clinical batches


Late development stage
  • Validation of analytical methods and consolidation of the CMC package
  • Stability studies and batch release monitoring
  • Batch release by HWI QPs
  • Management of partners for the clinical programme
  • Preparation and submission of dossiers for the investigational medicinal product (IMPD, IND)
  • Communication with the authorities
  • Consultation in marketing authorisation procedures
  • Creation of marketing authorisation dossiers in eCTD format
  • Applications for marketing authorisations and processing of RFIs and deficiency letters
  • Project and process management
  • GxP audits

Contact us. We’re happy to help!

Silvia Öttl
Sales Manager

Phone: +49 7272 7767-2561


Monday - Friday

+49 7272 7767-0