Drug Product Support

Analytical Development

We provide complete development of analytical methods for drug compounds, excipients and drug products to support our contracted customers. Analytical methods are developed and validated according to ICH guidelines and validated methods can either be transferred to us or developed at our group facilities to support technology transfer, scale up, process validation and ICH stability testing for bulk and packaged drug products.

Validation Support

Inthera PharmaMed Group in support of  manufacturing wide range of products with partnering group at Seatrack International Group, provides validation support which is tailored to your needs. We assist you in producing product quality reviews (including a complete package if requested) and support the renewal of your product approvals. Inthera PharmaMed is a reliable partner from planning and execution to evaluation and validation reporting of:

  • Products
  • Processes
  • Analytical Methods
  • IT-systems
  • Engineering Support for Equipment

Regulatory Support

Regulatory registration support for our contracted customers is organized according to the tasks and product ranges of various our facilities, where a team of experts in the relevant technology is available on-site for registration-related questions.

As new developments arise we produce all the documentation necessary for our clients to submit the file for registration in the selected markets. On request, applications for registration can be produced and submitted via reliable service providers with whom we work.

When products change, whether it be to meet changed requirements from the registration authorities, to improve products or to ensure that medicines are safe, we take care of all the documentation, so as to successfully implement change applications known as variations.

In addition, through our registration support for contracted customers we produce the documents that are needed to retain registration in relevant markets for the medicines already produced by our partnering facilities.

Clinical Supply Services

Inthera PharmaMed’s clinical trial units operate in close collaboration with formulation development and commercial manufacturing at Seatrack International Group to take advantage of the full range of capacities, resources and complete big pharma infrastructure offered by all of our facilities. They are comprised of:

Clinical Manufacturing

Comparator Procurement

Label Printing & Labeling

  • Label layout & approval
  • 100% inspection of all clinical labels (four-eye principle)
  • Documented 100% reconciliation
  • Generation of randomisation lists
  • Code-breaking envelopes
  • Multi-lingual booklet labels & wrap-around labels

Packaging / Pre-production Service

  • Interpretation of study protocols & conversion into optimized packaging design

Secondary Packaging

  • Syringes, vials & ampoules, visit boxes, patient kits, centre boxes, shipping boxes, graphic packaging design

Analytical / QA-Service

  • In-house lab
  • Analytical method development, transfer and validation
  • Stability tests according to ICH
  • Release testing
  • Issuance of CoA
  • QP release

Storage

  • Dedicated shipping warehouse area
  • Commercial warehouse
  • Cold Storage Room @ 2-8°C
  • Cold Storage Room & Freezer Storage @ -20°C

Distribution

  • Worldwide distribution
  • IVRS / IWRS
  • Shipment tracking with modern communication systems
  • Cold chain distribution management, including refrigerated & frozen shipment
  • Data logger system
  • Return drug reconciliation & management
  • Certified destruction