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.