Drug devleopment

Regulatory Services for Drug Development – The Right Strategy, Smooth Approval

  • News
  • Read time: 8 minutes

Developing a new drug or medicinal product? Feeling overwhelmed by the complex regulatory requirements before clinical trials? Let our regulatory experts guide you.

Our Nordic regulatory team at LINK Medical leads you through every step of early drug development. From CMC (Chemistry, Manufacturing & Controls) to non-clinical and clinical phases, we ensure your strategy aligns with current standards – minimizing risks and accelerating your path to first-in-human studies and beyond

Meet the Team

hilde foros drug development

Hilde Foros
Senior Regulatory Manager

Hilde holds a Master of Science in Biotechnology and has 25 years of experience in the pharmaceutical and biotech industry, the last 15 years as a CMC Regulatory Expert. She understands the requirements of the authorities and will pragmatically guide you in building and authoring a robust CMC strategy and documentation.

Drug devleopment 2

Why Partner with LINK Medical’s Regulatory Experts?

  • Regulatory strategy and guidance across CMC, non-clinical, and clinical planning.
  • Support with funding applications, due diligence, and target product profile workshops.
  • Gap analysis of existing documentation and preparation for scientific advice meetings.
  • Expertise in toxicology, pharmacology, PK/PD modeling, and translational science.
  • CMC advisory: formulation, manufacturing processes, stability, and GMP readiness.
  • Preparation of key regulatory documents: CTA/IMPD, IND, BLA, DMF, ASMF, CEP, MAA, NDA, etc.
  • Interim and operational project management with flexible insourcing solutions.
  • Local regulatory experts with international experience.

Expertise:

  • Non-clinical and Clinical Phase I–III development
  • CMC: small molecules, biologics, radiopharmaceuticals, ATMPs
  • Scientific advice / pre-IND
  • Orphan drug designation

Therapeutic Areas (not exclusive):

  • Rare disease
  • Oncology
  • CNS
  • And more across diverse therapeutic areas

Let us simplify the process — tell us about your regulatory needs today.

bd@linkmedical.eu

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