"Our Finished Formulation R&D Services are tailored to drive the development of innovative pharmaceutical products from concept through to commercialization. Our team of experts offers comprehensive support to ensure the successful development and launch of your finished formulations."
Services
Pre-formulation Studies
- Physicochemical Characterization & Compatibility
- Solubility & Stability
- Dissolution Testing
- Physical Characterization
- Solid State Characterization
- Stress Testing
Formulation Development
- Innovative Formulations: Developing robust formulations for oral, injectable, topical, and inhalation routes.
- Prototype Creation: We create prototype formulations for proof-of-concept, stability testing, and clinical trials.
- Scale-Up & Optimization: We ensure seamlessly transition from lab-scale to commercial production with optimized formulations.
- Post-Marketing Formulation Adjustments: Evaluating and implementing formulation changes post-approval, including new dosage forms and reformulations with alternate sources.
- Patient-Centric Solutions: We design formulations that enhance patient adherence and experience, including taste-masking and convenient dosing.
- Special Population Considerations: Tailoring formulations for specific patient groups, such as pediatrics and geriatrics.
- Clinical Support
- Clinical Trial Material (CTM) Manufacturing: Preparing formulations for clinical trials (Phase I to III) through CDMO.
- Dose Selection: Determining optimal dosage strengths based on preclinical and early clinical data through CRO.
- BA/BE Studies: Conducting bioavailability and bioequivalence studies to compare different formulations through CRO.
Pharmaceutical Analysis
- Drug Substance Analysis: Identification, quantification, impurity analysis, and stability testing of small organic compounds.
- Drug Product Analysis: Comprehensive formulation analysis and in vitro pharmacokinetic studies.
- Stability Studies: Conducting photostability and stability tests to ensure product quality and shelf-life.
- Analytical Method Development: Developing and validating methods for release testing, stability testing, and quality control.
- Packaging Development: Designing packaging solutions that maintain product integrity and support patient compliance.
Regulatory Support
Comprehensive Regulatory Guidance: Providing support for Europe MAH, IND, NDA, and ANDA submissions to ensure compliance and successful market entry.
Capabilities
- Oral Solid Dosage Forms
- Tablets, capsules, powders, and granules.
- Injectable Formulations
- Solutions and lyophilized products.
- Topical Formulations
- Creams, ointments, gels, and sprays.
- Liquid Formulations
- Solutions, suspensions, and emulsions.
Technical Machine Capabilities
- High Shear Granulation / Top Spray Granulation
- MUPS Compression
- Bilayer Compression
- Mini-Tablets
- Capsule Innovations:
- Powder in Capsule
- Pellet in Capsule
- Tablet in Capsule
- Capsule in Capsule
- Liquid in Capsule
- Hot Melt Extrusion: For thermally sensitive formulations.
- Roller Compaction: Dry granulation for moisture-sensitive products.
- Nanotechnology
- PFOS/GFOS and POC
- Injectables
Benefits
1.Accelerated Development
- Expedieted development timelines to bring your product to the market faster.
2. Enhanced Product Quality
- Robust formulations that provide efficacy, safety, and long-term stability.
3. Regulatory Expertise
- Comprehensive support to ensure compliance with global regulatory standards.
4. Cost-Effective Solutions
- Optimized formulations and processes designed to minimize development costs.
