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Drug Substance Development

Preclinical medicinal chemistry, process development and regulatory support from discovery to scale-up for diverse drug modalities, with seamless transition into our GMP facility.

Located in Uppsala, Sweden and Ter Apel, the Netherlands, our early phase analytical and process development team offers a comprehensive suite of (pre)clinical services.

We provide robust synthetic and analytical support throughout the medicinal chemistry journey, from initial hit identification to candidate drug selection. This includes:

  • Hit expansion
  • Lead optimisation
  • Synthesis of patent examples, prodrugs, and metabolites.

Once a candidate drug is selected, we can scale the synthesis to produce non-GMP material suitable for toxicological studies.

Our process development team explores novel synthetic routes, optimises reaction conditions using Design of Experiment (DoE) methodologies, and produces kilogram-scale verification batches. Adaptable operations enable us to pivot without panic, keeping your project on track through every twist and turn.

These capabilities are complemented by extensive analytical support, including impurity profiling, solubility and stability assessments, and bioanalytical services. We also offer analytical development as a standalone service.

Beyond small molecules, including controlled substances, our innovative scientific team has deep expertise in emerging modalities such as oligonucleotides, PROTACs, and bioconjugates, including antibody-drug conjugates (ADCs).

With transparent project management and a GMP mindset from day one, our in-house team secures the best possible timelines. We act efficiently but without haste, doing things Right First Time to keep momentum and protect your outcomes. Our regulatory affairs department can support the projects with any regulatory challenges.

Whether your molecule is a new chemical entity, a repurposed drug, or a generic compound, Ofichem is the partner who answers, solves, and remembers — supporting your entire journey from preclinical development to the market

Ready to take your innovation to market?

Work shoulder-to-shoulder with a family-owned CDMO and pharmaceutical supplier that answers quickly, solves early, and keeps your progress steady. Decisions feel clearer with us beside you.