Our Expertise

Every development journey begins with a challenge, an unpredictable API, a formulation that refuses to behave, a device platform that won’t reconcile with viscosity, a regulatory pathway that bends the timeline, or scale-up surprises that only surface when it’s almost too late.At Healios Labs, we convert these hurdles into momentum. With multidisciplinary command across formulation science, drug-device engineering, CMC development, and complex modality handling, we help innovators accelerate from concept to clinic with confidence. Our team thrives where most development pathways falter, non-linear solubility profiles, Q3-critical attributes, thermolabile APIs, complex controlled substances, or intricate PK–PD targets. Healios brings the precision of a scientific think-tank and the agility of a next-generation CDMO to every project.

Dosage Forms Expertise

At Healios Labs, dosage-form development is engineered as an end-to-end scientific pathway—beginning with preformulation intelligence, moving through process-design optimization, and culminating in commercial-scale manufacturability. Every program is de-risked through data-driven formulation strategies, advanced material-science characterization, and device–product compatibility mapping. Whether the challenge is solubility enhancement, aseptic precision, modified-release engineering, or complex delivery routes, Healios integrates deep technical fluency with industrial execution to deliver robust, regulatory-aligned products with predictable performance and seamless scale-up trajectories.

- - - - Topicals
      - Transdermals
      - Ophthalmics
      - Injectables (SVP & LVP)
      - Nasal sprays (unidose, bidose, multidose)
      - Inserts (suppositories, pessaries, bougies)
      - Otic
      - Implants (Subdermal, Ocular, Vaginal, Rectal)
      - Oral liquids

Drug Modalities

Healios Labs operates at the intersection of complex chemistry, biotransformation science, and advanced containment technologies to support an exceptionally broad spectrum of drug modalities. From highly potent APIs to structurally delicate peptides and carbohydrate-based scaffolds, our teams architect formulation and process solutions that stabilize challenging molecules, mitigate degradation pathways, and ensure dose-precision across delivery routes. By integrating high-resolution analytical control with modality-specific manufacturing infrastructure, Healios delivers development programs that are scientifically rigorous, cGMP-compliant, and ready for seamless transition into clinical or commercial supply.

- - Controlled substances (Schedule II–V)
  - Hormonal products
  - Steroidal products
  - Cytotoxic drugs
  - Synthetic peptides
  - Complex carbohydrates

Drug–Device Combinations

Drug–device combinations demand a sophisticated fusion of formulation science, human-factors engineering, micro-mechanical design, and performance-critical material selection. Each system must harmonize dose uniformity, device actuation mechanics, extractables/leachables control, container–closure integrity, and user-interface safety—all under stringent regulatory scrutiny. Healios Labs builds these hybrids with an integrated platform that aligns API behavior with device architecture, validates functional reliability through accelerated stress-mapping, and engineers delivery systems optimized for accuracy, usability, and lifecycle robustness. Our multidisciplinary ecosystem ensures seamless convergence of drug, device, and manufacturing design to achieve consistent, clinic-ready performance.

- - - - Prefilled & ready-to-go systems
      - Transdermal & dermal systems
      - Implantable drug–device hybrids
      - Nasal delivery with devices
      - Inhalation-based devices
      - Ophthalmic drug–device products

Novel Drug Delivery Systems Across Multiple Routes

Novel drug delivery systems require a sophisticated command of biopharmaceutics, tissue-specific transport mechanisms, excipient functionality, and device–interface optimization. Achieving targeted deposition—whether across dermal layers, ocular surfaces, pulmonary architecture, or mucosal pathways—demands precision engineering backed by mechanistic ADME insights. Healios Labs integrates advanced permeability modeling, rheological tuning, micro/nano-scale carrier design, and route-specific release engineering to build delivery systems that unlock therapeutic access where conventional formats fail. Our cross-route development framework ensures each platform is scientifically validated, manufacturable, and engineered for predictable in-vivo performance.

- - Dermal delivery
  - Ophthalmic delivery
  - Lung and nasal delivery
  - Rectal and vaginal delivery
  - Otic delivery
  - Ungual and transungual delivery

Para-IV Formulation Development

Para-IV development requires a strategic blend of formulation invention, regulatory dexterity, and deep mechanistic understanding of reference-listed drugs. The challenge lies in engineering a therapeutically equivalent yet non-infringing product by modulating composition, microstructure, release kinetics, or manufacturing pathways—without compromising QTPP alignment. Healios Labs brings patent-deconstruction expertise, excipient-function redesign, physicochemical pathway mapping, and complex-generic development capability to architect formulations that withstand legal scrutiny, achieve bioequivalence, and deliver first-to-file competitive advantage with technical defensibility.

- - Q1/Q2-different (non-equivalent) formulations
  - Alternative dosage forms
  - Alternative strength or release profiles
  - Polymorph, salt, or co-crystal switching
  - Excipient-function shift (mechanistic workaround)
  - Manufacturing-process differentiation
  - Abuse-deterrent strategy modification (OUD products)
  - Device or delivery-component modification
  - Complex generics–specific Para IV design

505(b)(2) Formulation Development

Navigating the 505(b)(2) regulatory pathway demands an intricate balance of scientific innovation, clinical justification, and regulatory strategy. Healios Labs excels in translating novel formulation concepts into viable products while ensuring alignment with FDA expectations. Our capabilities address key challenges including route modification, strength optimization, release profile engineering, and patient-centric design, while maintaining robust analytical characterization and device integration. From combination products to prodrug innovations, Healios delivers technically sound, scalable, and regulatory-ready 505(b)(2) solutions, minimizing development risks and accelerating time-to-market.

- - New dosage forms
  - New routes of administration
  - New strength or dosing regimens
  - Modified-release (MR / ER / DR) formulations
  - Novel excipients or novel excipient functions
  - Combination products (drug–drug or drug–device)
  - Reformulated complex products
  - New indication or patient population (with formulation support)
  - Prodrugs and salt/co-crystal variants
  - Reformulation for safety or tolerability improvements

NCE Formulation Development

Developing formulations for New Chemical Entities (NCEs) presents unique scientific challenges, from solubility and stability constraints to bioavailability optimization and early-stage enablement. Healios Labs leverages cutting-edge formulation science to address these hurdles, including advanced delivery platforms, prodrug strategies, and bioenhancement techniques. Our expertise spans preclinical to Phase I enablement, allowing seamless scale-up and integration with clinical supply chains. By combining mechanistic understanding with process engineering, Healios ensures robust, reproducible, and regulatory-compliant NCE formulations that maximize therapeutic potential while mitigating development risks.

- - Basic and conventional formulations
  - Non-conventional formulations
  - Specialty formulations
  - Advanced delivery systems
  - Solubility-enhancement formulations
  - Bioavailability-enhanced formulations
  - Prodrug-based formulations
  - Early-stage enablement formulations