• Regulatory Affairs
  • Biotech products

Biotech products

Do you want to use your biotech product as a biopharmaceutical or medical device?

With our teams in Regulatory Affairs, Development, Analytics and Quality, we will accompany you through all stages up to the successful authorisation of your biotech product. No matter whether you have questions about the implementation of GMP requirements, method development or your clinical development programme, we will help you create the necessary documentation and applications and will take care of contacting the authorities for you.

Biopharmaceuticals are often combined with medical devices for their administration and application, or used as part of a combination product. In these cases, you must also think of the MDR requirements. Please contact our specialists in the Medical Devices department.

Are you a new biotech company or start-up? We can offer you our full range of regulatory, analytical and technical services, as well as our network of specialists and partners, all from one source.

Are you a well-established biotech company and need some short-term support in order to deal with peak workloads? You can reach your targets easily with us.

#biotechproduct

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
  • Regulatory strategy for your drug candidates
  • 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

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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
Post-authorisation and distribution services
  • Life cycle management (e.g. updating dossiers, variations, renewals, line extensions)
  • Quality-related services (e.g. audits, QMS update, PQR)
  • Laboratory services (e.g. release testing)
  • Pharmacovigilance activities to safeguard the marketability of authorised products
  • Provision of QPs or QPPVs by the HWI group
  • Review and release of advertising materials

Contact us. We’re happy to help!

Dr. Andrea Klüting
Vigilance & Regulatory Affairs
Business Development HWI group

Phone: +49 89 2000203-60
Email:

Dr. Verena Peter
Quality/CMC

Phone: +49 89 2000203-71
Email:

Dr. Jürgen Epple
Quality/CMC

Phone: +49 89 2000203-95
Email:

Hotline

Monday - Friday
08:00 - 17:00 o´clock

+49 7272 7767-0