Development & Manufacturing
From early-stage formulation to commercial production. Galenic development, analytical services, stability programmes and GMP manufacturing across a certified network.
Development as an integrated discipline
Inventis treats development as a continuous chain, from pre-formulation studies on the active ingredient through analytical method validation, ICH stability programmes and the design of a robust, transferable industrial process. Each step is documented under a quality system fit for the regulated market.
Network capacity
Service blocks
Pre-formulation & formulation
API characterisation, excipient compatibility and target product profile co-definition for solid, liquid and semi-solid dosage forms.
Learn moreAnalytical development
Method development and validation against ICH and pharmacopeial expectations; HPLC, UPLC, dissolution and impurity profiling.
Learn moreStability studies
ICH long-term, accelerated and intermediate conditions across Zones II, IVa and IVb, covering GCC, Middle East and tropical markets. Photo-stability and transport simulation as required.
Learn moreProcess development & QbD
Applying ICH Q8/Q9/Q10 principles, including design of experiments, criticality assessment and risk-based scale-up, to build a manufacturing process that is robust, reproducible and ready for regulatory submission.
Manufacturing orchestration, not just production
Inventis coordinates pharmaceutical manufacturing through a qualified network of GMP-certified facilities. We select, audit and oversee every manufacturing partner, applying the same rigour that comes from two decades of building and running pharmaceutical factories in Europe.
From raw material release through in-process control, finished product release and packaging, each batch moves through a defined quality system with traceable batch records and documented deviation management.
Multi-site flexibility
Access to multiple production lines without capital expenditure. Capacity scales with the network, not with a single facility.
Independent oversight
Quality oversight is structurally separate from production. Inventis audits, monitors and releases, without the conflict of being both producer and supervisor.
Risk mitigation
No single point of failure. Supply continuity maintained across qualified alternatives within the manufacturing network.
Dosage forms across the network
Our manufacturing partners cover six dosage form families, with state-of-the-art technology and high levels of automation.
Oral solid
Tablets, coated tablets, capsules and sachets; granulation, blending, compression, coating and encapsulation.
Oral liquid
Syrups, oral solutions and suspensions; production, filtration, filling and capping under controlled conditions.
Semi-solid
Creams, ointments, gels and cutaneous solutions; high-shear mixing, deaeration and tube or jar filling.
Injectable
Small-volume (SVP) and large-volume (LVP) parenteral manufacturing across the network.
Tech transfer & scale-up
Inbound transfers are scoped against ICH Q10 expectations: gap analysis on the existing master batch record, equivalence experiments where required, validation batches under a defined protocol, and a transfer report that closes the loop with the sending laboratory.
- Receiving-site readiness assessment
- Process gap analysis
- Engineering and registration batches
- Process validation under PV protocol
- Transfer report and lessons learned
Packaging
Primary and secondary packaging coordinated across the network. Coding, serialisation and tamper-evident features handled under the same quality oversight system that governs upstream production.
- Blister, bottle and sachet primary packaging
- Cartoning, labelling and serialisation
- Tamper-evident finishing
- Artwork management and version control
Discuss a development or manufacturing project.
From a single API characterisation study to a full development-to-launch programme, we scope each engagement around the regulatory and commercial constraints of the target market.