Technical Consulting
When you think of picking up the best partner for your product surely you will think about the CRO having experience and resources with highly specialized skill sets and hands on therapeutic experience with reasonable cost.
We help our clients on Risk based decisions to meet the desired timelines
Formulation development (QbD based):
We can efficiently manage formulation development (NDDS, ANDA, differentiated dosage forms) analytical development, technology transfer, process development and project management and many other areas till successful approval and launch.
We have been developing processes for formulations by establishing parameters to achieve quality as per the ICH. We have developed and have expertise in integrated development of API and formulations.
We had been formulating non-infringing patentable strategies for immediate release, extended release capsules / tablets and multiparticulate delayed / modified release dosage forms.
End to end visibility (Selection to Launch) in developing various dosage forms like tablets, hard gelatin /, dry powder syrups / suspensions/ FDCs, bilayer tablets, Tablet in Tablet , tablets in capsules, Sachets, effervescent granules, ODTs and Taste masking, dry powder/ liquid injectable.
Process development and PAT Tool:
We are proficient in employing Quality by Design (QbD) in the development of drugs mitigates risks. By understanding all critical aspects of drug development and control strategies before running significant efforts on design space. We believe in program called “KYP” Know your product. Monitoring and evaluating product performance from pre-formulation to regulatory submission and launch. Characterization based OSDs and Injectables.
Bioequivalence Strategies & IVIVC:
Merit of developing bioequivalent strategies for ensuring desired pharmacokinetic response in dosage form design through identification of suitable bio-relevant media.
Platform technologies
We can create and execute new technology platforms for oral solids like HMEs, MUPS and many others. These technologies can help to create product differentiation and also help in managing product life cycle.
Regulatory & IP Services:
Our Regulatory Affairs team has competency in handling multiple regulatory needs.
We review regulatory requirement in detail, suggest ideas and provide support for quicker development at every step.
Our regulatory expertise ensures detail project planning and strategies to meet legislative requirements.
We offer a full range of regulatory services from designing of overall regulatory strategy to marketing authorization and post approval life cycle management.We are specialized in reviewing of Technical Dossiers