ndia has emerged as a formidable player in Active Pharmaceutical Ingredients (API), Key Intermediates and Formulations. Most of the countries across the globe consider India as one of the major sourcing base as India has largest number of USFDA approved facility outside the USA.Indian pharmaceutical companies face enormous challenges in terms of changing norms/regulations in the outsourcing process. Therefore to stay ahead of the competition, it becomes important for the pharmaceutical companies in India to have pool of experts by their side. This also can help companies cater their products to international markets and helps caleup the business operations to a global platform. However, most Indian pharmaceutical companies, especially the small sized and mid sized companies that have good approvable or approved manufacturing facilities, qualified manpower , good technical know-how mostly find it difficult to cater to an international market due to lack of exposure . On the other hand International companies face challenges in identifying reliable quality supplier /manufacturer.
Parul Ozawho had been working in the space for more than 29+ years at a senior management level,over time noticed a massive gap in the outsourcing segment. Hence, in 2003bridging the gap between the Indian and International market, she incepted Contract Research & Manufacturing Outsourcing Organization (CRMO) with the vision of providing complete out sourcing solutions to Pharmaceutical industry.
CRMO had a pleasant beginning owning to Parul’sextensive work experience in the pharmaceutical industry. This contributed to CRMO’s growth over the years and helped CRMO to builda solid foundation. Throwing light on Parul speaks, “We began with providing complete pharmaceutical outsourcing solution to few clients. Since we wanted to create an impact in the market, we started to work with many associates and experts from India and abroad. Gradually, we were able to add more clients and work for various projects across the globe.”
Complete Outsourcing Solution
Leveraging years of experience and knowledge of the Indian and International markets to find the best solution for the customers;CRMO ensures that their services take care of the overall cost containment of the customers with maximum deliverables investing minimum resources. The company leaves no stone unturned to help International clients identify suitable outsourcing partners and manage entire sourcing including QC/QA audits, facility audits, technology transfer, supply chain management, project coordination, and provide responsible care for the clients. “From identifying a suitable manufacturing site, to helping them on behalf of clients in cGMP compliances, regulatory approvals, facility modification and auditing the production site, we provide complete outsourcing solution which is very important for any pharmaceutical industry to maintain quality at all times, thereby helping clients attain sourcing goals”she says.
“Leveraging years of experience and knowledge of the Indian and International markets to find the best outsourcing solution; CRMO ensures that their services take care of the overall cost containment of the customers”
Added to this, CRMO provides entire gamut of services including cGMP product outsourcing, cGMP audits and compliances services, pharmaceutical and technology transfer project management, commercial production monitoring. Explaining about the flagship offering Parul avers, “Because of the vast experience with the Indian pharmaceutical industry, we have generated a database of good manufacturing facilities in India. These facilities have been identified based on detailed audits, surveys and technical feasibility studies. We have emerged as a preferred partner for sourcing API’s, advanced stage intermediates of including those of the near patent expiry API’s and niche specialty chemicals.”
CRMO based in Ahmadabad has a PAN India presence and has clients inthe U.S., Europe, and Japan. “The requirement for cGMP outsourcing solution provider in the pharmaceutical sector across the globe is gaining all the necessaryattention at the moment. We feel, as the sourcing needs are increasing, more companies will come to India with newer requirement. This newer requirement comes with newer set of challenges and weare here to play a vital role in helping our clients in the entire process,” concludes Parul.