About Promedipharm

About us

  • Founded in 1994
  • Independent service provider
  • More than 20 years experience in product development
  • Pharmaceutical entrepreneur
  • Manufacturing authorisation
  • In-house laboratory activities
Promedipharm key activities

Key activities

Drug development is the main focus of our activities, but we also assist you with medical devices.

Furthermore we help to customize your foreign product for the European market.

 

In the framework of clinical studies we provide trial medication with the related documentation.

We support your ongoing commercial production at a contract manufacturer including batch release activities.

With regard to regulatory affairs we develop strategies for your product and compile or maintain your dossiers.

We build your individual quality management system and assist in inspections by competent authorities or customer audits.

In the case of staff shortages we can offer project-independent temporary support.

Active Pharmaceutical Ingredients:

  • Synthesis
  • Optimization
  • Analytics
  • Development reports
  • Stability

Dosage forms:

  • Manufacture and release of clinical trial medication
  • Process validation

Analytics:

  • Implementation of in-process-controls
  • Determination of specifications
  • Method development
  • Reference substances

Regulatory affairs:

  • Determination of regulatory strategies
  • Preparation of registration documents (IMPD, CTD, eCTD) and Expert Reports
  • Evaluation of dossiers
  • Marketing authorization application to European authorities and support of registration procedures
  • Life cycle management
Contact Promedipharm

Contact

Imprint

PROMEDIPHARM® GmbH
Berliner Ring 89 · 64625 Bensheim

 +49 (0) 62 51 / 17 74 -0
 +49 (0) 62 51 / 17 74 -17
 info@promedipharm.de

Manager: Dr. Bernhard Hanke

Amtsgericht Darmstadt, HRB 24582

Volksbank Darmstadt-Südhessen eG
BIC: GENODEF1VBD
IBAN: DE 12 5089 0000 0053 100 600

Commerzbank München
BIC: DRESDEFF700
IBAN:DE 95 7008 0000 0665 575 000

Competent Supervisory Authority: Regierungspräsidium Darmstadt, Luisenplatz 2, 64283 Darmstadt.