Supporting the full drug discovery and
development continuum
No matter where you are in your drug development journey, we can provide you with a wide range of
products, models, services and guidance
that are tailored to your specific needs.
Custom Capabilities
Pharmaffiliates encompass a wide range of advanced pharmaceutical services tailored to support complex R&D needs. We specialize in the synthesis of both small and large molecules, including APIs, key intermediates, chiral standards, metabolites, glucuronides, and stable isotopes. Our expertise in deuterated compounds enables applications in reaction mechanism studies, biosynthetic pathway analysis, and improved metabolic stability. We also develop novel drug delivery systems with applications in dermatology, cosmetics, and nutraceuticals. Additionally, we offer impurity profiling and polymorphism studies to ensure product quality and regulatory compliance.
Analytical Capabilities
Pharmaffiliates support comprehensive method development and validation for APIs, formulations products, and their containers-ensuring specificity, linearity, accuracy, precision, and robustness. Method transfer is supported seamlessly across laboratories. Stability studies include R&D preliminary testing, QC-based stability assessments, release and comparator studies, and photostability evaluations. Structure elucidation is carried out using advanced techniques such as UV, HPLC, UPLC, FTIR, ICP, ICP-MS, chiral chromatography, and 1D/2D NMR, delivering reliable characterization and regulatory-compliant data.
Regulatory Services
Pharmaffiliates provide comprehensive regulatory services to support pharmaceutical research, including expert consulting, dossier preparation, and DMF/ANDA submissions. Our scientifically driven approach ensures global regulatory compliance, expedites approvals, and facilitates successful clinical and bioequivalence studies through accurate, research-focused documentation and strategic guidance.
Research-Focused Regulatory Consulting
Pharmaffiliates provides strategic regulatory consulting tailored to research environments, guiding scientists through global requirements (FDA, EMA, etc.) to ensure early-phase alignment, reduce development risks, and accelerate progression from lab to market.
Scientifically Aligned Dossier Preparation
Our experts compile CTD-format dossiers and ANDAs with a strong foundation in research data—ensuring clarity, compliance, and scientific accuracy to support successful evaluations and reduce regulatory queries.
Comprehensive DMF & ANDA Support for R&D
From detailed CMC documentation to global DMF and ASMF submissions, we streamline regulatory support for API research, clinical trial authorization, and bioequivalence studies—empowering researchers with compliant, submission-ready data.
Analytical Testing
Supporting research with precision, our analytical testing services cover everything from structural identification using IR, NMR, and Mass Spectrometry to detailed purity and assay assessments. With advanced techniques like 2D NMR and on-demand precision testing, we deliver the reliable data scientists need to drive discovery and development forward.
Structural Analysis
We support early-stage research with robust identification techniques including IR, 1D/13C NMR, and Mass Spectrometry, essential tools for confirming chemical identity and molecular structure in discovery and preclinical studies.
Purity & Quality Testing
Our chromatographic and elemental analysis services—HPLC, residual solvent testing, water content (KF/TGA), and sulphated ash—ensure compound integrity and quality essential for reliable experimental outcomes.
Precision NMR Services
Pharmaffiliates offers specialized NMR services such as 13C NMR, 2D NMR, and 2D NOESY for deeper molecular insights, supporting advanced research needs in structural elucidation and impurity mapping.
Training & Audits
Expert-led GMP/GLP training and independent third-party audits enhance pharmaceutical quality, compliance, and operational excellence. With over 60 training programs and 110 audits completed, these services empower professionals with practical skills and ensure alignment with global regulatory standards—supporting safer, research-driven pharmaceutical development and manufacturing.
Regulatory Skills Development
Expert-led, hands-on training programs that build practical skills in compliance, research, and operations for all levels of professionals.
Industry Impact
Over 60 programmes and 3,200+ professionals trained—empowering teams with the knowledge to meet evolving global quality and regulatory expectations.
Trusted Audit Services
Independent third-party audits conducted to EMEA standards ensure objective, high-quality evaluations that support regulatory approval and supply chain integrity.
Other
We provide advanced lab solutions, FTE-based services, and specialist consulting to assist your study. Under the direction of seasoned Ph.D. scientists, our team guarantees confidentiality, open communication, and dependable outcomes. Help us to meet world standards and confidently advance your research by producing efficient, cost-effective results.
Expert Research Support
Customized solutions including literature searches, lab techniques, and scientific consulting—driven by a skilled and experienced team.
FTE-Based Services
Flexible, full-time project engagement tailored to your needs with transparent costing and dedicated scientific teams.
Confidential & Compliant
Strict confidentiality, regular updates, and globally aligned practices ensure trust, quality, and peace of mind.
Custom Capabilities
Pharmaffiliates encompass a wide range of advanced pharmaceutical services tailored to support complex R&D needs. We specialize in the synthesis of both small and large molecules, including APIs, key intermediates, chiral standards, metabolites, glucuronides, and stable isotopes. Our expertise in deuterated compounds enables applications in reaction mechanism studies, biosynthetic pathway analysis, and improved metabolic stability. We also develop novel drug delivery systems with applications in dermatology, cosmetics, and nutraceuticals. Additionally, we offer impurity profiling and polymorphism studies to ensure product quality and regulatory compliance.
Analytical Capabilities
Pharmaffiliates support comprehensive method development and validation for APIs, formulations products, and their containers-ensuring specificity, linearity, accuracy, precision, and robustness. Method transfer is supported seamlessly across laboratories. Stability studies include R&D preliminary testing, QC-based stability assessments, release and comparator studies, and photostability evaluations. Structure elucidation is carried out using advanced techniques such as UV, HPLC, UPLC, FTIR, ICP, ICP-MS, chiral chromatography, and 1D/2D NMR, delivering reliable characterization and regulatory-compliant data.
Regulatory Services
Pharmaffiliates provide comprehensive regulatory services to support pharmaceutical research, including expert consulting, dossier preparation, and DMF/ANDA submissions. Our scientifically driven approach ensures global regulatory compliance, expedites approvals, and facilitates successful clinical and bioequivalence studies through accurate, research-focused documentation and strategic guidance.
Research-Focused Regulatory Consulting
Pharmaffiliates provides strategic regulatory consulting tailored to research environments, guiding scientists through global requirements (FDA, EMA, etc.) to ensure early-phase alignment, reduce development risks, and accelerate progression from lab to market.
Scientifically Aligned Dossier Preparation
Our experts compile CTD-format dossiers and ANDAs with a strong foundation in research data—ensuring clarity, compliance, and scientific accuracy to support successful evaluations and reduce regulatory queries.
Comprehensive DMF & ANDA Support for R&D
From detailed CMC documentation to global DMF and ASMF submissions, we streamline regulatory support for API research, clinical trial authorization, and bioequivalence studies—empowering researchers with compliant, submission-ready data.
Analytical Testing
Supporting research with precision, our analytical testing services cover everything from structural identification using IR, NMR, and Mass Spectrometry to detailed purity and assay assessments. With advanced techniques like 2D NMR and on-demand precision testing, we deliver the reliable data scientists need to drive discovery and development forward.
Structural Analysis
We support early-stage research with robust identification techniques including IR, 1D/13C NMR, and Mass Spectrometry, essential tools for confirming chemical identity and molecular structure in discovery and preclinical studies.
Purity & Quality Testing
Our chromatographic and elemental analysis services—HPLC, residual solvent testing, water content (KF/TGA), and sulphated ash—ensure compound integrity and quality essential for reliable experimental outcomes.
Precision NMR Services
Pharmaffiliates offers specialized NMR services such as 13C NMR, 2D NMR, and 2D NOESY for deeper molecular insights, supporting advanced research needs in structural elucidation and impurity mapping.
Training & Audits
Expert-led GMP/GLP training and independent third-party audits enhance pharmaceutical quality, compliance, and operational excellence. With over 60 training programs and 110 audits completed, these services empower professionals with practical skills and ensure alignment with global regulatory standards—supporting safer, research-driven pharmaceutical development and manufacturing.
Regulatory Skills Development
Expert-led, hands-on training programs that build practical skills in compliance, research, and operations for all levels of professionals.
Industry Impact
Over 60 programmes and 3,200+ professionals trained—empowering teams with the knowledge to meet evolving global quality and regulatory expectations.
Trusted Audit Services
Independent third-party audits conducted to EMEA standards ensure objective, high-quality evaluations that support regulatory approval and supply chain integrity.
Other
We provide advanced lab solutions, FTE-based services, and specialist consulting to assist your study. Under the direction of seasoned Ph.D. scientists, our team guarantees confidentiality, open communication, and dependable outcomes. Help us to meet world standards and confidently advance your research by producing efficient, cost-effective results.
Expert Research Support
Customized solutions including literature searches, lab techniques, and scientific consulting—driven by a skilled and experienced team.
FTE-Based Services
Flexible, full-time project engagement tailored to your needs with transparent costing and dedicated scientific teams.
Confidential & Compliant
Strict confidentiality, regular updates, and globally aligned practices ensure trust, quality, and peace of mind.
