Services

Tablets, capsules, granules and powders made to order, from formulation to the certified batch.

Solutions, syrups, creams and ointments manufactured and filled to order.

Injectables, infusions, lyophilisates and prefilled syringes made under aseptic conditions.

Primary and secondary packaging, blistering, labelling and serialisation to order.

Active substances synthesised or fermented under GMP, from grams to tonnes.

Antibodies, proteins, cell and gene therapies developed and manufactured to order.

Chemical and physical testing of APIs, excipients and finished products under GMP.

Sterility, endotoxins, microbial purity and environmental monitoring to order.

Stability studies to ICH Q1A: storage in climate chambers, testing at set time points, report.

Drug levels and biomarkers measured in blood and tissue samples, including for clinical trials.

Analytical methods developed, validated to ICH Q2 and transferred to other laboratories.

An external Qualified Person certifies batches and takes responsibility under Section 14 AMG.

Manufacturers, suppliers and service providers audited and qualified to GMP and GDP.

Quality systems set up, inspections prepared, deviations and CAPA handled.

Marketing authorisation dossiers, variations and communication with BfArM, PEI and EMA.

Clinical trial applications prepared and submitted through CTIS, including the IMPD.

Adverse reactions collected and reported, PSURs written, QPPV provided.

Clinical trials planned, run, monitored and analysed, from phase I to IV.

Trial sites selected, patients recruited and studies supported on site.

Equipment, rooms and utilities qualified (DQ, IQ, OQ, PQ) and processes validated.

GxP software validated to GAMP 5, with data integrity secured.

Cleanrooms planned, built, qualified and monitored to EU GMP Annex 1.

Medicines stored and transported under the GDP guidelines, with temperature records.