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. Recently, a partner approached us with a thermolabile API that broke down during conventional processing. Our team quickly identified a novel formulation pathway, incorporating specialized temperature controls and protective excipients, and delivered a stable product ready for clinical trials on schedule. 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, we approach dosage-form development as a comprehensive scientific process, from preformulation analysis and process design to commercial-scale manufacturing. We reduce risk in every program by applying data-driven formulation strategies, advanced materials science, and device-product compatibility assessments. Whether addressing solubility, aseptic processing, modified-release systems, or complex delivery methods, Healios leverages technical expertise and industrial capability to deliver robust, regulatory-compliant products with reliable performance and efficient scale-up.

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 provides specialised formulation and process development services for complex and high-risk drug products. We support highly potent APIs, controlled substances (Schedule II–V), hormonal and steroidal products, cytotoxic drugs, synthetic peptides, and complex carbohydrates.

Our expertise combines advanced containment technologies, biotransformation science, and high-resolution analytical control to stabilize challenging molecules, reduce degradation, and improve dose precision across delivery routes. With modality-specific manufacturing infrastructure and cGMP-compliant processes, we help move development programs toward clinical and commercial supply.

Controlled substances (Schedule II–V)

Hormonal products

Steroidal products

Cytotoxic drugs

Synthetic peptides

Complex carbohydrates

Drug–Device Combinations

Drug–device combination products require a careful balance of formulation science, human-factors engineering, device design, and material selection. Healios Labs develops these complex systems with an integrated platform that supports dose uniformity, device actuation, extractables and leachables control, container–closure integrity, and user safety under strict regulatory requirements. We align API behavior with device architecture, validate functional performance through stress testing, and engineer delivery systems for accuracy, usability, and long-term reliability.

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 expertise in biopharmaceutics, tissue-specific transport, excipient functionality, and device-interface optimization. Achieving targeted deposition across dermal layers, ocular surfaces, pulmonary pathways, and mucosal routes requires precision engineering supported by mechanistic ADME insights. Healios Labs combines advanced permeability modeling, rheological optimization, micro- and nano-scale carrier design, and route-specific release engineering to develop delivery systems that improve therapeutic access where conventional formats fall short. Our cross-route development framework ensures each platform is scientifically validated, manufacturable, and built 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 innovation, 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 requires a careful balance of scientific innovation, clinical justification, and regulatory strategy. At Healios Labs, we turn novel formulation concepts into viable products while aligning with FDA expectations. Our 505(b)(2) development capabilities address route modification, strength optimization, release profile engineering, and patient-centric design, supported by robust analytical characterization and device integration. From combination products to prodrug innovations, we deliver technically sound, scalable, and regulatory-ready solutions that help minimize development risk and accelerate 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 and development challenges, from solubility and stability constraints to bioavailability optimization and early-stage enablement. At Healios Labs, we apply advanced formulation science to overcome these hurdles through innovative delivery platforms, prodrug strategies, and bioenhancement techniques. Our NCE development expertise spans preclinical to Phase I enablement, supporting smooth scale-up and integration with clinical supply chains. By combining mechanistic understanding with process engineering, Healios delivers robust, reproducible, and regulatory-compliant NCE formulations designed to maximize therapeutic potential and reduce development risk.

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