From concept to commercialization - expert CDMO services including formulation development, method development, stability studies, technology transfer, and commercial-scale GMP manufacturing for global pharmaceutical partners
GLOBAL REACH
From concept to commercialization - expert CDMO services including formulation development, method development, stability studies, technology transfer, and commercial-scale GMP manufacturing for global pharmaceutical partners with full regulatory compliance, proper documentation, and secure logistics.
Advanced pre-formulation and development studies
Commercial-scale cGMP manufacturing capacity
Validated tech transfer from pilot to commercial batches
OUR CAPABILITIES
End-to-end formulation development and contract manufacturing solutions from concept to commercial launch
Product design, excipient selection, dosage form optimization, bioavailability enhancement techniques, taste masking, stability improvement, and formulation scale-up from lab to pilot to commercial batches.
HPLC/GC method development, dissolution testing, impurity profiling, analytical method validation as per ICH Q2(R1), stability-indicating methods, and QC testing protocols.
Complete process transfer documentation, equipment qualification, batch replication studies, process validation at commercial scale, and regulatory filing support for global markets.
Commercial-scale production in WHO-GMP certified facilities, batch sizes from pilot (10K units) to full commercial (10M+ units), complete batch documentation and CoA generation.
ICH-compliant stability studies (long-term, accelerated, intermediate), photostability testing, freeze-thaw studies, forced degradation studies, and regulatory submission support.
DMF preparation, CTD Module 3 compilation, product development reports, validation protocols and reports, and complete regulatory dossier for ANDA/MAA submissions.
DOSAGE FORM CAPABILITIES
Full-service CDMO capabilities across all major dosage forms with advanced manufacturing technology
Tablets, capsules, sachets, powders - immediate release, sustained release, enteric-coated, bi-layer, tri-layer, ODTs
Syrups, suspensions, oral solutions, drops - pediatric formulations, taste-masked, sugar-free, preservative-free
Lyophilized injections, sterile liquid injectables, pre-filled syringes, ampoules, vials - aseptic manufacturing
Ointments, creams, gels, lotions, transdermal patches - topical, dermatological, cosmeceutical applications
Nutraceuticals, herbal products, probiotics, sachets, effervescent tablets, chewable tablets, gummies
Pain relief, cough/cold, vitamins, minerals, digestive health, skincare - complete OTC portfolio development
HOW IT WORKS
Streamlined workflow ensuring efficient formulation development and commercial manufacturing
API characterization, target product profile definition, formulation strategy selection, excipient compatibility screening, and timeline estimation with proposal generation.
Prototype formulations, excipient screening, optimization studies, analytical method development, pilot batches, and bioavailability studies
Equipment qualification, process parameter optimization, batch scale-up from R&D to pilot to commercial, process validation runs
Manufacturing procedure transfer, batch manufacturing records, equipment specifications, training of production staff, and validation batches
GMP commercial production, in-process quality control, finished product testing, batch release with full CoA, and packaging
DMF preparation, CTD Module 3 documentation, stability data compilation, regulatory submission support, and post-approval changes
CDMO DELIVERABLES
Complete CDMO documentation package for regulatory submissions and manufacturing
Comprehensive report documenting formulation development, optimization studies, and scale-up activities
Master batch records, SOPs, in-process controls, and finished product specifications
Complete method validation reports per ICH Q2(R1) for all analytical procedures
ICH-compliant stability data (accelerated, long-term, photostability) with statistical analysis
Process qualification documentation (IQ, OQ, PQ) and continued process verification
Complete transfer documentation, training records, comparative batch data, and validation summary
Complete CMC section including drug substance, drug product, and appendices for regulatory submission
Batch-specific CoA with all quality parameters, test results, and conformance to specifications
VISUAL OVERVIEW
Our R&D laboratories, analytical testing, and cGMP manufacturing operations
Partner with our CDMO experts for complete product development, manufacturing, and regulatory support. From formulation to commercialization - we deliver excellence.
Certified
Approved
Certified
Compliant
Ready