HALIX can offer you client specific complementary services in the life cycle management of your product, for example in supply chain management, packaging changes and reformulation
When outsourcing to HALIX you get a full service package of expert development activities, high quality GMP manufacturing services and a comprehensive QC package. Our in-company qualified persons can release your product for use in a clinical trial.
We offer labeling and packaging of biopharmaceutical products with custom layouts and randomization. We can test machinability with your preferred vials and caps on our filling line, or we can offer you a range of standard primary packaging. Depending on your wishes secondary packaging requirements can also be realized.
HALIX has Qualified Persons who can offer QP batch release and certification of GMP manufactured batches. Every GMP batch we manufacture is accompanied by a Certificate of Compliance (CoC) and a Certificate of Analysis (CoA). We can also release your product for use in a clinical trial. Auditing of another contractor throughout the supply chain may then be required.
Our regulatory department can offer (pre-)clinical regulatory support and commercial regulatory support. This includes dossier development for:
(pre-) Investigational New Drug (IND)
Investigational Medical Product Dossier (IMPD)
Biologics License Applications (BLA)
Marketing Authorization Applications (MAA)
Annual Product Reviews (APRs)
Product Quality Reviews (PQRs)
Post approval variation filing