Pharmaceutical Outsourcing has been called, “One of the greatest organizational and Industry structure shift of the century”. Because of relatively shorter life cycles of newly developed drugs and intense generic competition, International companies need to improve their operational efficiencies with significant cost containment and give more thrust on their core competencies like Drug Discovery. Many companies are routinely outsourcing their regular production to cost effective off shore locations like India, so that their maximum efforts and resources are spent on the research and development activities. India is now becoming a sourcing hub for the International Pharma Industry for their technology transfer and contract manufacturing projects
India is proving out to be a preferred outsourcing location for many Pharmaceutical companies. It is a member of the BRIC countries and is one of the most important Pharmerging market.
Due to the availability of the large English speaking scientific talent pool, India offers end to end solution across the drug development spectrum including drug discovery; clinical trials; contract manufacturing, product licensing and commercial supply. Indian Pharma Sector shows Sound understanding of global regulatory benchmarks. Having larger number of USFDA approved sites in India - biggest number other than the US - is a testimony to this fact. It offers strong manufacturing bases with flexible approach for partnering through tech transfer, product in-licensing and contract research and manufacture and has a comparable business philosophy to western world.
However, outsourcing to India is not without its own Challenges. Geopolitically and culturally diverse India poses its own complexities to the companies looking for outsourcing. More
Need of total Outsourcing Project Management
Success of any Outsourcing Project requires streamlined and uninterrupted work flow, strong interface between the manufacturers and suppliers and minimizing the cultural differences between the east and the west. Therefore, a local presence at the suppliers’ end to manage the customer’s outsourcing activity can help complete their projects on time. As opposed to the internal project managers, external project managers can have a very unbiased and wholesome outlook for Project completion.
CRMO offers unmatched pharmaceutical project management services to the International Pharmaceutical Industry. Because of the following attributes, we feel that we are well positioned to take care of diverse contract manufacturing and Pharmaceutical technology transfer project management activities.
1. CRMO has a proven track record of managing many outsourcing projects on behalf of many US, European and Japanese Companies.
2. We have in-depth knowledge of Indian Pharmaceuticals and Chemical Industry.
3. We’ve understanding of Outsourcing trends and their growth drivers.
4. CRMO shares excellent rapport with leading Indian manufacturers.
5. CRMO is backed by competent techno commercial work-force.
Scope of Pharmaceutical Project Management Services:
The entire scope of Pharmaceutical Project Management Services is divided into 5 phases:
1. Identification of suitable suppliers.
2. Project design phase.
3. Project development phase.
4. Project approval phase.
5. Post approval support phase.
1. Identification of the suitable supplier:
1. Identify, interview, analyse and screen potential partners.
2. Conduct technical and financial due diligence.
3. Co-ordinate and conduct preliminary assessment visits.
4. Assist on the Contract negotiations beneficial for both the parties.
5. Assess and improve the quality systems of the chosen partner if needed by conducting GMP audits and then follow up on the audit findings.
2. Project Design Phase:
1. Define the scope of the project.
2. Benchmark the milestones with firm deadlines keeping in view the final submission dates.
3. Assess the potential risks in the scope of the project and have risk management plans firmed up.
4. Break up the activities into major and minor activities and interlink them so that each individual milestone is met without any slippage.
5. Final WBS chart to be signed off in mutual agreement of both the partners.
6. Finalizing the cross functional teams and firming up reporting systems to track the progress of the project.
3. Project Execution Phase:
1. Review of development documentation.
2. Ensure the readiness of the facility for undertaking exhibit batches by conducting facility audit and documentation review.
3. Monitor the tech transfer/site transfer activities on behalf of the customer, including the process validations and related documentation.
4. Project Approval Phase:
1. Assist the suppliers in preparing the submission documents.
2. Support during the regulatory inspections.
3. Support for redressing queries, warning letters and in audit compliance so that the products get registered.
5. Post-Approval Support Phase:
1. Upon approval, monitor the GMP standard of the supplier by acting as a Third Party GMP auditor on behalf of the MNC, for routine production.
2. Monitor the supply chain management and ensuring uninterrupted product supply for routine manufacture.
3. In case of any product complaints and related emergencies, act as a local representatives of the MNCs and ensure effective investigations.
Benefits of choosing CRMO Pharma as your Project Manager:
1. CRMO Pharmatech is strategically located in India to cater to the needs of the MNCs by being their “Eye and Ear” in India, thereby making our services extremely cost-effective.
2. In case of any emergencies/ project delays. CRMO would ensure that quick attention is given to such emergencies and all necessary support is provided to the suppliers to tackle the delays and keep the project on track.
3. During all important milestones of Project (Like exhibit batches, regulatory audits) CRMO representatives shall be present with the suppliers to physically verify the status, thus, cutting down the expenses for the MNCs on overall resources including travel costs and time.