Formulation and API Development Services by Pharmaffiliates
Company Overview
Pharmaffiliates is a global pharmaceutical research organization specializing in API development, impurity reference standards, formulation development, analytical method development, and contract research services. Established in 2001 and headquartered in Panchkula, Haryana (India), the company has expanded its footprint across the 90+ Countries, supporting pharmaceutical, biotechnology, and healthcare organizations worldwide.
Pharmaffiliates’ scientific infrastructure enables comprehensive R&D solutions that align with FDA, EMA, ICH, USP, and EP regulatory expectations, while ensuring data integrity, quality, and compliance throughout the drug development lifecycle.
Formulation Development Services
Formulation development is critical for transforming active pharmaceutical ingredients into stable, safe, and effective dosage forms. Pharmaffiliates provide end-to-end support for both New Chemical Entities (NCEs) and generic formulations, in accordance with global regulatory frameworks.
Pre-Formulation Studies
Pre-formulation studies evaluate the physicochemical characteristics of an API, such as solubility, polymorphism, hygroscopicity, pKa, and stability, providing the foundation for dosage-form design and excipient selection. These studies aid in establishing biopharmaceutical attributes as per ICH Q6A (Specifications) and USP guidelines.
Key Activities:
|
Parameter Studied |
Objective |
|
Solubility profiling |
Assess dissolution and bioavailability potential |
|
Stability under stress conditions |
Evaluate degradation pathways (ICH Q1A) |
|
Excipient compatibility |
Identify suitable formulation components |
Formulation Optimization
Following pre-formulation, Pharmaffiliates optimizes the formulation to achieve desired release kinetics, stability, and patient suitability. Capabilities include multiple dosage forms:
|
Dosage Form |
Development Capability |
|
Tablets & Capsules |
Solid oral formulations including immediate, sustained, and modified-release systems |
|
Oral Suspensions |
Stable and uniform liquid formulations for oral administration |
|
Injectable Solutions |
Sterile parenteral formulations designed for stability and efficacy |
|
Lyophilized Formulations |
Freeze-dried sterile products to enhance shelf life and stability |
|
Transdermal Patches |
Controlled drug delivery systems offering sustained release through the skin |
|
Topical Gels & Creams |
Formulations designed for local or systemic delivery with optimized absorption |
|
Inhalation Formulations |
Solutions, suspensions, or dry powders for pulmonary or nasal delivery |
|
Suppositories & Ointments |
Semi-solid dosage forms for rectal or vaginal administration |
|
Nutraceutical & Specialty Formulations |
Custom formulations for health supplements and niche applications |
The use of Design of Experiments (DoE) and lab-scale optimization ensures robust formulation attributes aligned with ICH Q8 (Pharmaceutical Development).
Regulatory Compliance
All formulations developed by Pharmaffiliates are aligned with FDA, EMA, and ICH regulatory expectations, ensuring smooth dossier submission and accelerated global market approvals.
API Development & Custom Synthesis
APIs form the pharmacological core of every drug product. Pharmaffiliates deliver API development and custom synthesis for small and large molecules through a CRDMO-based service model, supporting R&D through commercialization.
Custom Synthesis
Solutions include synthesis of:
- Chiral compounds for advanced research
- Stable isotopes for metabolic studies
- Key intermediates and reference standards
Impurity Profiling
Impurity profiling supports safety, purity, and regulatory compliance in line with ICH Q3A/Q3B. Pharmaffiliates performs identification, quantification, and characterization using:
- High-Performance Liquid Chromatography (HPLC)
- Ultra-Performance Liquid Chromatography (UPLC)
- Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
Analytical Services
Analytical characterization is performed using advanced instrumentation, including:
- Nuclear Magnetic Resonance (NMR)
- Fourier-Transform Infrared Spectroscopy (FTIR)
- Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
These capabilities support method development, stability assessment, and dossier data generation.
Integrated Services for Accelerated Drug Development
Method Development & Validation
Analytical methods are developed and validated in accordance with ICH Q2 (Validation of Analytical Procedures) to ensure accuracy, precision, specificity, linearity, and robustness.
Stability Studies
Stability studies are conducted as per ICH Q1A Guidelines to determine product shelf-life, degradation behavior, and suitability of packaging conditions.
Regulatory Support
Regulatory support includes:
- CTD Dossier Preparation
- ANDA/DMF Support
- Global Regulatory Consultation
Why Choose Pharmaffiliates?
- High purity API and impurity reference standards
- Advanced analytical expertise (HPLC, NMR, ICP-MS)
- Compliant with ICH, FDA, and EMA frameworks
- CRDMO model supporting end-to-end development
- Global presence and reliable technical support
Conclusion
Pharmaffiliates deliver comprehensive formulation and API development solutions backed by regulatory alignment, analytical excellence, and global scientific capability, helping organizations advance molecules from concept to commercialization with confidence.
FAQs
- What services do Pharmaffiliates offer? Pharmaffiliates provides API development, formulation development, impurity profiling, analytical testing, custom synthesis, and regulatory support.
- Which dosage forms can Pharmaffiliates develop? Tablets, capsules, suspensions, injectables, and lyophilized formulations.
- Do Pharmaffiliates follow global regulatory guidelines? Yes, all work aligns with ICH, FDA, and EMA standards.
- What analytical techniques are used? NMR, FTIR, ICP-MS, HPLC, GC, LC-MS, and more.
- Can Pharmaffiliates support regulatory submissions? Yes, including DMF, ANDA, and CTD dossier preparation.
