Competences

Packing/repacking
HB-Medical is a contract manufacturing organization specialized in filling and packing small and medium series. Repacking can consist of altering the package size, labelling, replacing (products) inserts, adding batch numbers and/or expiration dates to label. All the processes are performed in compliance with cGMP, i.e batch documentation, accountability and traceability.

Clinical trials
We offer randomized packaging and logistics related to clinical trials. Distribution of medicinal products
at ambient temperature as well as cold chain distribution are a natural part of our competences.

The distribution of patient-packed investigational products entails detailed co-ordination, amongst which regulatory green light must be awarded prior to any delivery as well as a QP batch release certificate.

Consultancy
Our consultants are specialized in GMP/GDP/GCP and master several languages. Depending on specified contracts with the customer we are able to act as QPs, prepare the relevant documentation for GDP or GMP approvals or give advice in clinical trials logistics and supply, regarding QA issues.

Quality
Procedures take place in an environment of a dedicated and professional staff respectfull of ethics.
Client confidentiality is fully ensured as is product traceability.

An audit of our company by a customer is always welcome, as it gives us the opportunity to improve the high quality standards we strive for.

  • Packing/Repacking
  • Clinical Trials
  • Consultancy: GMP, GDP, GCP
  • Batch release QP
  • Training and Education
  • Audits
  • High Quality
  • Timely delivery
  • Dedicated employees
  • Client confidentiality
  • Flexibility


 

HB-Medical ApS - Kanalholmen 25-29 Build 6 - DK-2650 Hvidovre - Denmark - Tel. (+45) 3649 5500 - Fax (+45) 3649 5507 - This e-mail address is being protected from spambots. You need JavaScript enabled to view it.