CMO, CDMO, nearshoring, raw materials or quality documentation. Choose your starting point and tell us what your next decision needs.
Describe the active ingredient, intended product category, target market and the evidence you already hold. For solubility or dissolution work, state the target and available methods. We start with feasibility and an agreed technical scope; stability, bioavailability and product performance require their own evidence.
Include the intended population, dose presentation, excipient constraints, batch scale and forecast volume. We assess formulation, analytical needs and manufacturing readiness within the applicable authorised scope, together with your technical and regulatory team.
We review the product category, dosage form, target market, materials, packaging and expected scale.
In-development dossiers and commissioned programmes are discussed case by case. Data readiness, ownership, licensing rights, territory and the MAH role are agreed explicitly. Specialist regulatory offices may be engaged.
Development or transfer work, validation, supply volumes, milestones and quotation follow the technical assessment.
We assess molecule class, non-sterile dosage form, handling needs, analytical readiness and transfer route. The programme is scoped after the technical and authorisation review.
Explore the scope →EIREN and Firmie are being developed by Sikalias Pharmaceutical Laboratories. They are not yet available for sale and no launch date has been announced.
EIREN & Firmie · R&D ↗