One-stop pharmaceutical R&D outsourcing services covering the entire chain from pharmaceutical studies, quality research, BE studies, to regulatory submission. Reduce multi-vendor coordination costs, shorten R&D and submission timelines, and minimize handover risks from fragmented outsourcing. Chemical Drug Formulation · Sustained/Controlled Release · Nano Drug Delivery — full technology route coverage.
From project evaluation to NDA approval — six core stages seamlessly connected. Each stage corresponds to specialized R&D service capabilities, ensuring unified quality, efficiency, and regulatory compliance.
Formulation composition analysis
Release mechanism study
Critical quality attribute confirmation
API property characterization
Excipient compatibility
Formulation design & risk assessment
Dissolution curve modeling
Process parameter DoE optimization
Lab/pilot scale-up validation
Dissolution profile f₂ comparison
Impurity & assay method validation
Stability studies
Fasting/fed BE protocol design
Pre-BE study strategy
Clinical CRO coordination & management
CTD dossier writing
Query response studies
On-site inspection support
Each stage has its own technical challenges and regulatory requirements. Taikomed has established mature methodological systems and project execution experience at every stage, ensuring seamless handover across the full process.
Systematic reverse engineering of the originator's formulation composition, release mechanism, and critical quality attributes. Establishes the QTPP to provide a scientific basis for subsequent formulation development.
Formulation Composition Analysis · CQA ConfirmationSystematic characterization of API critical physicochemical properties (solubility, polymorphism, particle size, permeability) and BCS classification determination, combined with risk assessment to formulate a development strategy.
BCS Classification · Excipient CompatibilityQbD-driven formulation and process development — DoE experimental design to optimize formulation variables, establish design space, and support step-wise scale-up from lab to GMP pilot manufacturing.
DoE Optimization · Process Scale-UpMulti-pH dissolution profile f₂ factor comparison, impurity method validation, content uniformity studies, and stress/accelerated/long-term stability testing.
f₂ Factor · Method ValidationFasting/fed BE protocol design, pre-BE study strategy, IVIVC modeling to predict in vivo behavior, clinical CRO screening and project management — significantly reducing formal BE failure rates.
Pre-BE · IVIVC ModelingProfessional CTD dossier preparation for Module 2 (QOS) and Module 3 (Quality), query response strategy, CDE communication strategy, and full production site inspection support.
CTD Writing · Query ResponseOutsourcing different R&D stages to multiple CROs introduces handover costs, communication overhead, and quality management risks. Unified full-process management significantly reduces project risk.
| Comparison Dimension | Full-Process One-Stop CRO | Fragmented Multi-Vendor Outsourcing |
|---|---|---|
| Stage Handover | Seamless connection across all stages — formulation, quality, BE, and registration data managed under one system | Risk of data loss, redundant verification, and cognitive bias at stage transitions |
| Communication Efficiency | Single project leader, single communication channel, rapid decision-making response | Multi-vendor coordination with high communication costs and difficult alignment |
| Quality Consistency | Unified quality system and documentation standards — fully traceable throughout | Different CROs use different systems, leading to inconsistent data formats and quality standards |
| Development Timeline | Parallel progression and coordinated scheduling — typically 15-25% shorter overall timeline | Serial progression with waiting periods between handovers — extended overall timeline |
| Issue Traceability | Single responsible party — clear issue traceability and rapid response | Blurred accountability boundaries with high risk of buck-passing and slow response |
| Regulatory Strategy Consistency | Regulatory requirements considered from formulation stage — coherent submission pathway | Fragmented outsourcing often leads to inconsistent regulatory strategy, increasing query risk |
Full-process CRO services are built upon deep technology platform capabilities. Each platform has a dedicated专题 page detailing its R&D capabilities and project experience.
Covering four technology routes: matrix, membrane-controlled, osmotic pump, and pulsatile release. Full-process CRO services from RLD characterization to BE study and drug registration submission. Over 10 years of experience in SR/CR formulation development and consistency evaluation.
View SR/CR Technology Details →Full coverage of four nano drug delivery systems: liposomes, nanoparticles, lipid emulsions/drug-loaded emulsions, and microemulsions. Supports generic drug development and Category 2.2 improved new drugs — from formulation & process development to CTD dossier writing and complex injectable registration submission.
View Nano Drug Delivery Details →One of the few CRO platforms in China covering the full range of parenteral nutrition lipid emulsions, drug-loaded lipid emulsion injections, three-chamber TPN bags, and Category 2.2 improved new drug lipid emulsions. 20+ product project matrix; TPN bag CRO is virtually untapped by competitors.
View Lipid Emulsion / TPN Bag Details →Beyond the three deep technology platforms above, Taikomed has established mature service capabilities in chemical drug formulation CRO, API & excipient development, TCM development, clinical studies, and regulatory affairs.
Browse our Services section for more details.
On the surface, fragmented outsourcing may appear cheaper per stage, but hidden costs are often overlooked: ① data handover and redundant verification costs between stages; ② management overhead of multi-vendor communication; ③ timeline extension from fragmented outsourcing increases time cost (each year of delay means reduced patent life and market exclusivity). While full-process engagement may have a slightly higher quote, the overall cost-effectiveness is often superior when considering handover efficiency, management costs, and timeline reduction.
Absolutely. Taikomed supports flexible service models — whether full-process one-stop engagement or single-stage commissioning (e.g., formulation development only, quality research only, or regulatory submission support only), we can customize the service plan to client needs. We also support starting with a single stage and expanding to full-process collaboration as the project progresses.
The typical full-process timeline for a generic drug consistency evaluation is approximately 2.5–4 years — pharmaceutical development (including preformulation, formulation process reverse engineering, pilot scale-up, quality research) takes about 12–18 months; BE studies take 6–8 months; and regulatory review takes 12–18 months. The actual timeline depends on product complexity, technology route, and regulatory review progress. The advantage of full-process CRO is the ability to shorten the overall timeline through parallel progression (e.g., initiating BE protocol design during the later stages of pharmaceutical development).
Oral solid dosage forms (immediate release / sustained & controlled release / enteric), injectables (including complex injectables such as lipid emulsions, liposomes, nanoparticles, TPN bags), semi-solid dosage forms, API and excipient development, and TCM development. Sustained/controlled release formulations, nano drug delivery systems, and lipid emulsions/TPN bags are our three core technology platforms, offering differentiated competitive advantages in the industry.
Collaboration process: ① Contact us and submit product information — ② Our technical team provides a complimentary product evaluation and R&D strategy recommendation — ③ Both parties discuss and agree on the scope of collaboration, technology route, and commercial terms — ④ Sign the collaboration agreement and initiate the project. The entire process typically takes 2–4 weeks. Call our consultation hotline or send an email for a complimentary evaluation.
From project evaluation to NDA approval — one-stop R&D outsourcing services. Contact our technical team today for a complimentary product evaluation and development strategy consultation.
📞 Hotline: +86-29-81107958 ✉️ Email Inquiry