Technology transfer into Europe
Bring your formulation, methods and process knowledge. We assess what can transfer, what needs further work and how the receiving site would be qualified.
Nearshoring for Complex Molecules or Biotechnological Startups. Connect formulation development, technology transfer and manufacturing planning with a partner in Greece.
Our starting point is your drug product: non-sterile dosage forms, analytical readiness and a programme defined around your molecule.
Whether you are relocating an existing programme, building your first drug product or exploring a second European source, start with a technical conversation. We bring R&D and manufacturing into the same discussion, so the next decision is grounded in your product.
Bring your formulation, methods and process knowledge. We assess what can transfer, what needs further work and how the receiving site would be qualified.
Define the dosage form, analytical needs and development sequence before committing to a manufacturing programme. Agree staged work packages around the evidence you already have.
Discuss supply continuity through an additional European manufacturing route. Site fit, transfer data, validation and regulatory responsibilities are evaluated before supply is agreed.
Choose your objective and continue with a focused enquiry.
FOR THE FIRST TECHNICAL DISCUSSION
Existing formulation · analytical methods · process data · target market
Continue with this objective →Complexity can sit in solubility, stability, moisture sensitivity, oxygen exposure or process transfer. We start by understanding that challenge and assessing whether our available platform can address it.
Discuss formulation or reformulation, analytical development, stability planning and pilot work. Deliverables are defined against your product and target market.
A low-humidity room below 10% RH and nitrogen capability on selected liquid lines support the evaluation of moisture- or oxygen-sensitive formulations. Suitability is established per process.
Oral liquids, semisolids, capsules, tablets and powders across a connected development and manufacturing model in Athens. The selected dosage form and site must fit the authorised scope.
Our nearshoring offer centres on non-sterile drug-product development and manufacturing. For complex molecules, feasibility depends on the material, dosage form, potency and containment requirements, analytical methods and stability profile.
A biotechnology startup does not necessarily need biologics manufacturing. If your programme requires biological drug-substance production, cell culture or fermentation, cell or gene therapies, sterile processing or aseptic fill-finish, raise this at the outset: these are not presented here as established Sikalias capabilities. We first determine whether there is a suitable role within our documented scope.
Review scope and quality documentation →Discuss development and manufacturing together with the Sikalias team, with site selection and QA involvement tied to the project.
Define work packages, data needs, decision points and commercial assumptions before agreeing the programme. Timing and batch scale follow the assessment.
Agree confidentiality, IP and dossier rights, material responsibilities, regulatory roles and the quality agreement. Exchange confidential information through an agreed channel.
We can assess a technology-transfer programme. Share the dosage form, dossier status, methods, current manufacturing location, expected volumes and target markets. A proposal follows the assessment of the technical and authorisation fit.
Yes. A non-confidential outline is enough to begin. Explain the molecule class, intended dosage form and development stage. We will discuss the available evidence and the work needed to define a suitable drug-product programme.
These depend on the product, equipment fit, process, analytical readiness and validation needs. We agree them for the specific programme rather than publish a universal commitment.
The molecule or product class, dosage form, development stage, target market, approximate scale and the main transfer or formulation challenge. Please do not submit patient data or confidential dossiers through the initial enquiry form.
Share a short, non-confidential outline. We can then discuss product fit, technical priorities and the route to a scoped development or transfer programme.
Discuss my nearshoring project →