Product Sourcing- APIs, Formulations
The keys to the strategy involve using long-term suppliers early in the...
Sourcing is a talent management discipline which is focused on the identification, assessment and engagement of quality, compliant, timely supplies and cost effective product sources. Literally scouting for a secondary manufacturer in order to support a principal manufacturer's manufacturing commitments. Be it API, intermediates, formulations, Biologics, Biosimilars and so on.
The keys to the strategy involve using long-term suppliers early in the development process so that the control strategy for their manufactured material can be developed over time and included in all supporting registration studies. From a business perspective, a supplier’s performance during product development can also be used as a predictor of long-term supplier success. Therefore it is essential to engage in source development at all stages of the API’s development.
The API Development process consists of Technology Identification, Screening for Commercial Sources, Developing Commercial Sources over Pre-clinical, clinical consisting of phase-I, phase-II, phase-III and then the supply. It is here Cito helps you identify a CMO sources to a principal manufacturer who expects GxP compliance at all these stages including cGMP for the manufacturing.
Investing Towards Goals: Validation and Long-term Supply Validation campaign of the CMO is a structured and constant activity and Cito would keep Principal manufacturer needs in mind for course corrections if need be from time to time including Risk Mitigation plans, technical diligence and quality audits.
This would ensure supplier Continuation Ensuring of a reliable pharmaceutical supply chain begins with a well designed process and proper material and supplier selection, and is sustained through on-going stewardship of the client – supplier relationship. Taken together, these steps will provide a satisfactory business arrangement where each company can expect many years of successful business dealings. Cito strives to establish such relationship among its associates.
We at Cito believe that while it is ideal to look at such scenario, in the practical side, a moderate principal manufacturer would look for a moderate secondary manufacturer Cito Healthcare solution is destined for delivery at door step across any part of the world. We dedicate our know how to the service of customers in the pharmaceutical industry worldwide. We know the Indian and Chinese market in depth and have mastered the issues associated with the manufacturing and sourcing of API and finish pharmaceutical formulations. Cito Healthcare covers every step in this chain, from process research till product delivery.
Cito Healthcare solutions offers uncompromised low cost production and sourcing of Active Pharmaceutical Ingredients (API). Beside cost benefits, we insist highest quality of products and reliability of sources to ensure a sustainable supply chain.
Our focus is on tailor made solutions as per your needs and with our sound knowledge of local market experience, we manage all activities promisingly.
Cito Healthcare solutions is a customer service driven company. We take pride in being knowledgeable, friendly, and efficient. We provide a diverse, yet comprehensive suite of products and services covering all facets of private labeling from product formulation to manufacturing to custom packaging solutions.
We also offer complete turnkey solutions to our customers for almost every finished products. Every step of the way, pharmadesk is dedicated to the success of our clients from our products, formulations so that you can concentrate on your distribution network, marketing and sales.
We supply products in various permitted/suitable dosages forms and sizes in form of small volume liquid parenteral, dry powder injectable, tablets (uncoated, sugar coated, enteric coated, film coated, chewable, sustained release and dispersible forms), capsules, dry syrups, liquid orals, sterile eye drops and ear drops and topical lotions for external applications for distribution as well as for social security Tenders.
Cito’s Clinical Development Services comprises of various services such as Bioavailability/Bioequivalence studies, Clinical Trials and allied supporting services for the pharmaceutical industry for their submission to regulated and semi regulated market. Having a basket of associates, Cito is uniquely structured to support the needs of healthcare industry during all stages of clinical development, whether be a complete bioequivalence study or a clinical trial management program. We are capable to provide you assured quality to answer your clinical need. We organize for our associates various pre-clinical and Clinical Development Services such as
Expected studies on toxicity and others on small animals, large animals both in GLP and non-GLP environments.
Phase-I for those products manufactured in India Phase-I from Second cohort on-wards for those products manufactured outside of India
BA/BE studies on both healthy and patient populations
Clinical Trials Services for Phase II-IV
The services such as Protocol Design, Clinical Phase, Volunteer Recruitment, Site management, Analysis of Biological Samples, Statistical Analysis and Report Writing Services can also be provided on pay per service basis to suit study requirement.
This segment is headed by Dr.Jonnalagadda Satyanarayana Prasad, who is an eminent scientist and has many papers to his credit on medicinal rice to his credit.
Cito through its networking capabilities brings together academic institutions to collaborate and leverage on mutual strengths nationally and internationally in terms of student exchange, faculty exchange, twinning of the programmes,
The pharmaceutical industry manufacturing and service processes change constantly as it is technology and regulatory intensive industry. In line with the industry requirements, Cito supports its needy associates in finding a right person for a right position. Having placed a person, his/her training needs too are taken care in line with its partner’s policies in the areas of GxP covering but not limited to GMP, GCP, GLP, GDP are the focus areas. Also regulatory accreditations including ISO 9001-2008, ISO 14000, SHE related approval etc. Celebrate People HR Solutions is the channel partner of Cito in this regards