CRMO — The ultimate outsourcing solutions provider to Pharmaceutical Industry .
CRMO Pharmatech is an Ahemdabad based company established with a vision of providing complete outsourcing solutions to Pharmaceutical Industry. Our focus is to help companies identify suitable outsourcing partners and manage entire sourcing project including QC & QA audits, facility audits, technology transfer, supply chain management, project coordination, and responsible care for the clients.
Our workforce keeps itself updated on trends in pharmaceutical market, API and Formulation technology, intellectual property, regulatory guideline, cGMP and SHE (safety, health and environment). CRMO has to her credit, successful implementation and execution of many outsourcing and technology transfer projects & assignments for the clients worldwide .The products range from In-patent APIs (Active Pharmaceutical Ingredient), Generic APIs, KSMs(Key starting materials also known as building blocks), to various Formulations .
This has been possible due to our successful working relationships with reputed Indian Pharmaceutical Companies. Our services ensure overall cost containment for our customers with maximum deliverables investing minimum resources. We leverage our years of experience and knowledge of the Indian and International markets to find the best solution for our customers. CRMO maintains a panel of experts from both the USA and India and our practical work experience with all regulatory agencies has resulted in a high success rate for our clients.
cGMP Product Outsource
Identifying, finalizing and monitoring suitable outsourcing partners befitting customer’s requirements for contract manufacturing and tech transfer projects. Due to our vast experience with the Indian Pharma 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 APIs, advanced stage intermediates of including those of the near patent expiry APIs and niche specialty chemicals. We also conduct GMP audits on regular basis for ensuring quality systems management at the sites we identify.
Complying with cGMP is mandatory in all pharmaceutical manufacturing. Regulatory agencies worldwide are authorized to conduct unannounced inspections, though some are scheduled. Routine domestic inspections by regulatory agencies are usually unannounced. Each ofthe inspectorates carry out routine GMP inspections to ensure that drug products are produced safely and correctly.
In the Pharmaceutical Industry, facing such inspections and exhibiting complete compliance is a very challenging task. Preparations before Inspections and demonstration of compliance post inspection with respect to the observations become key to future supplies to regulated market places.
Our team of experts from India, USA and Europe provide Industry with various services that can help them sail through such inspections successfully. We assist companies prepare compliance reports and response to audit observations as well help them implement CAPA as per regulatory guidelines.
Besides regulatory inspections, many customer audits take place at the manufacturing sites. We prepare sites for successful customer audits so that the continuity of supplies can be maintained.
Pharmaceutical & Technology Transfer Project Management
We specialize in managing outsourcing projects on client’s behalf to prevent project overrun. We monitor all major milestones in the scope of the project to ensure project completion as per the required regulatory benchmarks. Our local presence makes sure that a particular project progresses ahead without any deviation in the timelines or the desired regulatory benchmarks. Our involvement makes certain that the project is executed in a transparent manner and the issues causing delays are raised and discussed openly for quick resolution. The outcome for our customers is overall reduction in the resources spent, completion of the project as planned and timely launch of the product in the market.
Monitoring the supplier to ensure uninterrupted commercial production, consistent quality and timely delivery. We achieve this because of our strategic locations in India where majority of good pharmaceutical manufacturers are located . CRMO representatives visit the facilities regularly to ensure smooth uninterrupted production with full compliance to the cGMP norms.