Formulation Development Services for Pharma, Biotech & Generics
Pharmaceutical formulation development plays a decisive role in turning an API into a safe, stable, and effective drug product. With increasing regulatory expectations and complex molecules entering development, pharma companies rely on specialized CROs/CRDMOs for robust, scalable, and compliant formulation solutions.
Our formulation development services support early R&D to clinical batches, ensuring your product meets quality, stability, and regulatory requirements.
Overview of Our Formulation Development Services
Developing a formulation is far more than mixing an API with excipients. It involves understanding how the molecule behaves, anticipating its stability and performance challenges, and engineering a dosage form that maintains safety and efficacy throughout its lifecycle. Whether supporting a new chemical entity or a generic product, our formulation development approach is systematic, data-driven, and aligned with global regulatory expectations.
Our workflow covers:
- Pre-formulation studies
- Formulation design and optimization
- Analytical method development
- Stability and compatibility assessment
- Scale-up and technology transfer
- Documentation for regulatory submissions
Pre-Formulation Studies (ICH Q6A)
Pre-formulation lays the scientific foundation for dosage-form design. By characterizing an API early, we help predict development risks and determine the most suitable formulation strategy.
Key Parameters Assessed
- Solubility Profiling: Establishes dissolution behavior and guides solubility-enhancement strategies.
- Polymorphism: Determines solid-state forms and their influence on stability and bioavailability.
- Hygroscopicity: Identifies moisture sensitivity and implications for packaging/storage.
- pKa, LogP/LogD: Supports understanding of ionization, permeability, and formulation route.
- Thermal Behavior (DSC/TGA): Detects melting transitions and potential interactions.
- Excipient Compatibility: Identifies excipients that maintain API integrity.
- Stress Stability (ICH Q1A): Helps map degradation pathways.
These insights help prevent downstream formulation failures and streamline optimization.
Formulation Optimization (ICH Q8)
After understanding the API, we refine formulation attributes using a structured scientific approach. Our team employs Design of Experiments (DoE) and systematic screening to identify excipient combinations, release profiles, and stability-enhancing strategies.
Dosage Forms We Develop
- Tablets & Capsules: IR, SR, MR, DR formulations with optimized dissolution performance.
- Oral Suspensions: Stable and uniform suspensions for improved patient compliance.
- Injectable Solutions: Sterile aqueous and non-aqueous formulations.
- Lyophilized Products: Freeze-dried options for improved shelf life.
- Transdermal Patches: Controlled-release systems enabling sustained drug delivery.
- Topical Gels & Creams: Designed for targeted or systemic delivery.
- Inhalation Formulations: DPI, solution, and suspension-based delivery.
- Suppositories & Ointments: Tailored for rectal or vaginal administration.
- Nutraceutical Formulations: Customized for specialized health applications.
This stage ensures the formulation is robust, manufacturable, and suitable for scale-up.
Regulatory-Compliant Development
Every formulation we develop is aligned with global expectations:
- FDA 21 CFR
- EMA guidelines
- ICH Q6A, Q8, Q9, Q10 standards
- USP and EP monographs
This alignment reduces regulatory queries and supports smooth dossier submissions.
API Development & Custom Synthesis Support
As a CRDMO, our capabilities extend beyond formulation. Our API development and custom synthesis teams support small and large molecules, including:
- Chiral compounds
- Stable isotope-labeled compounds
- Key intermediates
- Impurities and metabolites
- Reference standards
This integrated approach ensures seamless communication between API and formulation teams, accelerating project timelines.
Impurity Profiling (ICH Q3A/Q3B)
We provide comprehensive impurity characterization for both API and formulations using:
- HPLC/UPLC
- GC/GC-MS
- ICP-MS
- LC-MS/MS
- FTIR
- NMR
These datasets support safety evaluations, stability studies, and regulatory filings.
Analytical Services for Product Development
Analytical R&D is central to formulation success. We offer:
- Assay & related substances analysis
- Dissolution method development
- Stability-indicating method development
- Solid-state characterization
- Thermal analysis
All methods are validated as per ICH Q2.
Stability Studies (ICH Q1A)
We conduct:
- Accelerated stability studies
- Long-term stability studies
- Photostability assessments
- Forced degradation studies
- Packaging compatibility evaluations
These studies determine product shelf life and degradation pathways.
Regulatory Support
We assist partners with:
- CTD dossier preparation
- ANDA/DMF filing support
- Global regulatory consultation
- Method validation data compilation
- Technical documentation for queries
Why Pharmaffiliates
- Proven expertise across complex APIs and specialty formulations
- Advanced analytical infrastructure (HPLC, NMR, ICP-MS, LC-MS, GC)
- Integration of API, impurity, and formulation development
- Compliance with FDA, EMA, and ICH frameworks
- Strong global presence and technical communication
Conclusion
Pharmaffiliates deliver scientifically strong, regulatory-ready formulation and API development solutions. With a focus on precision, analytical excellence, and global compliance, we help organizations move molecules from concept to commercialization efficiently and confidently.
FAQs
- What formulation services do you offer? We provide pre-formulation, formulation optimization, analytical development, stability studies, and regulatory support.
- Which dosage forms do you specialize in? Tablets, capsules, suspensions, injectables, lyophilized products, topicals, inhalation systems, and more.
- Do you follow global regulatory standards? Yes, we follow ICH, FDA, EMA, USP, and EP guidelines.
- What analytical techniques do you use? HPLC, GC, NMR, FTIR, LC-MS/MS, ICP-MS, DSC, TGA, and more.
- Can you support regulatory submissions? Yes, including CTD dossiers, ANDA/DMF support, and query responses.
