Contract Development & Manufacturing Organization
From development to scale-up and manufacturing, DRK combines scientific expertise, operational agility, and quality-driven execution to reduce risk and accelerate your path to market.
“We do not just work for you-we work with you, combining Swiss quality with global agility.”
CDMO core services
Flexible scopes ranging from targeted development activities to complete product delivery and commercial readiness.
DEVELOPMENTFormulation, analytical method development, process development, commercial manufacturing, validation strategy and regulatory-ready documentation aligned for efficient scale-up.
TRANSFERRobust, scalable formulations and fully documented transfer of data, materials and process know-how to qualified CMOs or partner-designated manufacturing sites.
PARTNERSHIPStructured collaboration combining partner commercial insight with DRK scientific expertise, milestone driven execution, transparent governance and aligned strategic objectives.
MANUFACTURINGScalable, compliant manufacturing solutions from scale-up to commercial production, ensuring consistent quality, efficient supply, and reliable product availability.
CLINICALIMP development, clinical manufacturing, customized packaging and integrated logistics supporting pharmaceutical GMP requirements, proof-of-concept studies and subsequent clinical phases.
REGULATORYEnd-to-end regulatory support across EMA, USFDA, MHRA, EAEU and WHO covering eCTD Modules 2–5, BE study coordination, regulatory submissions, post-approval lifecycle management, GMP readiness and market access.
OUT-LICENSINGOur integrated platform supports strategic out-licensing of late-stage, near-approval and commercially ready assets-helping partners enter markets faster with controlled investment risk, with three partnership models including commercial supply, complete tech transfer and ready-to-submit dossier.
From concept to commercial
Scientific Coverage
DRK’s scientific team brings deep formulation, analytical and regulatory expertise across key therapeutic categories — with focused capability in complex generics, niche products and hybrid 505(b)(2) formulations that demand specialized development approaches.
Antibacterial agents, antiviral therapies, and antifungal agents.
Antipsychotics, antidepressants, and anxiolytics.
Acne management, psoriasis treatments, eczema and dermatitis therapies.
Acid-related disorders (GERD, peptic ulcers), inflammatory bowel diseases, IBS and anti-emetic disorders.
Diabetes management, dyslipidemia, obesity management, thyroid disorders and metabolic syndrome.
Multivitamins, mineral supplements, immunity boosters, probiotics & prebiotics and antioxidant formulations.
Solid tumor therapies, hematological malignancies and targeted therapies.
Glaucoma management, dry eye disease, allergic conjunctivitis, and post-surgical ophthalmic care.
NSAIDs, analgesics, neuropathic pain management, anti-inflammatory and rheumatologic disorder treatments.
Asthma management, chronic obstructive pulmonary disease (COPD), allergic rhinitis, and antihistamines.
Maternal health, reproductive health and general wellness.
Emerging focus: monoclonal antibodies (mAbs), recombinant proteins, CAR-T therapies, and gene therapy.
Formulation & Manufacturing
At DRK, we combine scientific depth with integrated CDMO capabilities to deliver complex and specialized dosage forms under a single, streamlined development and manufacturing platform. Our expertise extends beyond formulation — we focus on solving technical challenges, optimizing performance and aligning every product with its regulatory and commercial objectives.
Immediate-release, modified-release, effervescent, enteric-coated and chewable tablets.
Hard and soft gelatin capsules.
Sachets and stick packs.
Age-appropriate oral dosage forms.
Solutions, suspensions, syrups and drops.
Ophthalmic solutions & suspensions, preservative-free unit-dose systems, sterile injectable solutions and suspensions (vials and ampoules).
Sterile ophthalmic gels and ointments, topical creams, ointments, gels, dermal sprays and foams.
Dry powder inhalers (DPIs), metered dose inhalers (MDIs) and nasal sprays.
DRK specializes in 505(b)(2) and hybrid development programs, including reformulations, new strengths, new routes of administration and combination products.
We actively collaborate with partners on rare and orphan drug development, supporting regulatory alignment to efficiently address unmet medical needs — from gap analysis and regulatory pathway assessment through clinical bridging and dossier preparation.
Why DRK
Your next program
Talk to DRK about your development, technology transfer, out-licensing, manufacturing or regulatory requirements.
Confidential project discussions can be initiated through our contact team.
