Rx therapeutics
Semi-solid technologies
As your trusted Rx therapeutics development and manufacturing partner, we strive to be the driving force behind your next breakthrough product. From initial formulation to final packaging and delivery, we handle it all.
Our expertise spans liquid and semi-solid over-the-counter (OTC) monograph, Rx and new drug application (NDA) manufacturing, including topicals, nasal sprays, and oral dose liquids. We employ game-changing proprietary technologies to achieve results that exceed expectations.
Our Rx solutions:
Always advancing
Backed by decades of experience, world-class facilities and a relentless focus on quality and compliance, we deliver tailored solutions that ensure your product’s success from concept to commercialization.
- End-to-end Rx solutions: We cover the full product lifecycle from formulation and clinical trials to scalable manufacturing and full-scale commercial support.
- Regulatory excellence: Compliance with FDA cGMP, ISO 9001/13485 and global regulatory standards ensure safety, quality and approval success.
- Scalable, flexible manufacturing: Our FDA-registered facilities in Largo, FL and Cleveland, TN can handle small clinical batches to full-scale commercial production.
- Proven expertise: Decades of success with complex OTC formulations like aerosols, topicals and nasal sprays provide a seamless transition to Rx.
- Dedicated regulatory affairs: Navigating FDA submissions (IND/NDA) and global approvals with confidence.
- Patient safety first: Rigorous testing and risk management protocols to ensure consistent quality and efficacy.
Tackling healthcare's biggest challenges
We're the trusted partner of pharmaceutical and consumer healthcare companies worldwide, including many of the global leaders. Our mission is clear: To empower our clients to develop game-changing solutions that address unmet patient needs and elevate existing treatments.
- Full-service partner: We manage all stages of your Rx product’s journey, from R&D to post-launch pharmacovigilance.
- Regulatory expertise: Our team simplifies the complexities of FDA approvals and ensures your product meets all compliance milestones.
- Scalable manufacturing: Flexible capacity to grow with your needs, delivering cost-efficiency without compromising on quality.
- Quality obsessed: We operate under stringent FDA cGMP guidelines and industry-leading quality standards (ISO).
- Tailored solutions: Every project is customized to meet your specific timelines, compliance requirements and market goals.
A dedication to reliable quality and compliance
All our facilities operate under global pharmaceutical standards, guaranteeing that quality and regulatory compliance are embedded into every single tiny detail. We maintain GMP production facilities, cGLP laboratories and registrations with all relevant regulatory authorities. This allows us to confidently meet the rigorous demands of pharmaceutical development, from clinical trials to commercial-scale manufacturing.
Our regulatory registrations:
- Certified cGMP Facility
- FDA Registered for Rx, OTC, cosmetics and medical devices
- EPA, ATF
- Florida Department of Health, Florida Bureau of Pharmacy
- Health Canada, Korean Ministry of Food & Drug Safety
- ANVISA (Brazil), EMA (EU), MHRA (UK), TGA (Australia)
- ISO, UL, NSF
Ever tried the Formulated Solutions approach?
Delivering excellence since 1999 from the forefront of innovation. Pushing boundaries and challenging the status quo underpinned by a bedrock of reliable quality. We're more than just a CDMO – we empower our clients to deliver impact with every action.