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