SmaBioLabs product development solutions
Product Development: Possibilities to patient-focused solutions SmaBio Labs’ approach blends art and science, from pre-formulation to product launch, ensuring your products are safe, effective, compliant and patient-focused.
1. Pre-Formulation
Rigorous testing to ensure compatibility between drugs and excipients. Detailed study of physical and chemical properties of drug substance and excipients.
Proof-of-concept Batches & Lead Identification: Develop initial batches to prove formulation feasibility and identify optimal candidates through screening.
Drug/Excipient Compatibility & Physiochemical Characterization: Rigorous testing of binary and tertiary mixtures of API and excipients to ensure compatibility.
2. Formulation Development
Ensuring product integrity and compliance through meticulous testing and well-defined stability studies.
Formulation Optimization & Process Identification: Enhance the lead formulation for optimal performance, while identifying scalable and reproducible manufacturing processes.
ICH Stability Studies & Packaging Material Selection & Studies: Assessing stability under accelerated, room temperature and intermediate conditions to ensure product shelf life.
3. Process Development & Scale-up
Optimize and scale up manufacturing processes to ensure efficiency, consistency, and readiness for large-scale production.
Process Optimization: Refining processes to maximize productivity and minimize costs.
CTM Manufacturing: Manufacture cGMP batches for bioavailability and bioequivalence studies.
4. Generic Product Development
Develop cost effective, bioequivalent and first-to-file generic products.
Brand Formulation & Stability: Reverse engineering of RLD & Brand formulation to develop effective and stable products.
In-vitro Bioequivalence Analysis: Comprehensive testing to confirm in-vitro bioequivalence for generic products eligible for biowaiver.
5. Nutraceuticals & Dietary Supplements
Develop and deliver safe and compliant nutraceuticals and dietary supplement products.
Regulatory Compliance and Commercialization: Create and manufacture quality products in strict compliance with FDA regulations and DSHEA act.
Ready for Global Markets: Products tailored for both domestic and international markets.
6. Cosmetics Development & Manufacturing
Providing end-to-end solutions from concept to consumer in the cosmetics industry, ensuring products are both innovative and compliant.
Formulation & Production: Expert formulation and production of cosmetic products under cGMP conditions, tailored to market needs and consumer preferences.
Development & Manufacturing: Initial concept and formulation to full-scale manufacturing and packaging, ensuring safe and superior skincare, makeup, and hair care solutions.