The Biggest Challenges in Pharmaceutical Outsourcing

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Pharmaceutical companies are facing times of unprecedented challenge; expiring patents, generics competition, clogged pipelines, pricing pressures, huge R&D costs, all contribute to major revenue losses. Is outsourcing the “pain killer” for this highly regulated industry? What are the biggest challenges in pharmaceutical outsourcing? 

• Language Obstacles, Cultural Gaps and Time Zones

The preferred outsourcing option is off shoring (the company providing the outsourced services is in a low-cost country far from the country where the recipient of services is located);  consequently the language barrier can oftentimes slow down the communication process and  lead to potentially dangerous misunderstandings.

Different time zones can be responsible for delays in data transfer and compromised deadlines.

Cultural gaps may be the source of erroneous perceptions, especially if there is not a cross- functional and cross-geographical team involved.

• Performance, Quality and Regulatory Requirements
  

When a company is looking for CRO and CMO partners it should be aware of domestic and foreign regulatory requirements.

Due-diligence auditing will be necessary to thoroughly evaluate the alignment of the two parties for the upcoming technology transfer.

Contracts must be written, and the company must conduct quality oversight of all contract manufacturers have a written quality agreement and other documents, to clearly identify the responsibilities of each party.

It is important to have a project team working together on both ends in a proactive manner, targeting dates, batches, and resources.

• Clinical Trials, Ethics

Outsourcing clinical trials called for pressing awareness because there are no regulatory agencies with trained people and resources to actually monitor all drug trials overseas.

There are some international and country guidelines, and laws, but their effective implementation is unclear. Companies must be assertive in discussing the outsourcing of clinical trials and provide information on their standards.

Transparency must be reinforced by the presence of ethics committees. 

• Logistics and Distribution, Supply Chain and Counterfeiting

Logistics and distribution must grant brand security and supply chain optimisation trough product serialisation, electronic pedigree documentation andeffective tax rate (ETR).

Due to regulatory requirements and limited outsourcing options, it may be challenging, at times, to find the right supply chain strategic partner; however, once partnership is accomplished, he must comply with new regulationsto combat product counterfeiting, and concur to supply chain visibility and control.

The outsourced partner must have cold chain management specialists, securing biotech and pharmaceutical companies’ strict regulatory compliance and product control.

Many pharmaceutical companies that outsource major projects, can end up managing relationships at arm’s length, because distance and lack of visibility of project progress , may foster problems that will  take more time to identify; often times the key to a successful outsourcing strategy in off shoring countries, lies in having a company person in place to mitigate business risks.

Contributor:   Cristina Falcão

- Lawyer – Portuguese Catholic University Lisbon (own practice – 1992 – 2003)

Published Law Articles (in Portuguese) http://www.box.net/shared/ru12sn0tgk

- Pharmaceutical Manager /Chief Science Officer/ Change Manager (2003 – current)

 At Farmácia F., Portugal.

• Vast Professional Experience and Knowledge both in Law and Pharmaceutical Issues; Working in Both Areas.
• Considered to Possess Strong Forecasting and Analytical Capabilities, Strategic Planning Experience, and Proven Leadership Ability with Diverse Multi-Cultural Peers and Employees
• Fluent in English, French, Italian, Spanish, Portuguese, and  a Moderate Knowledge of The German Language

Other areas of work and interest:

• Promotion of Public Health Programs, like “Living With Diabetes”
• Director of all Mandatory Recalls and Pharmaco Vigilance
• Qualified in Change Management Control
• Certification of Quality for Pharmacies
• Marketing for Pharmacies
• Conflict Management
• Familiar With Supply Chain Topics
• Trained in Cold Supply Chain Distribution of Drugs to Pharmacies
• Supporter of Technology Innovation Relating to Pharmacies and Supply Chains
• Assistance to Supplier of Pharmacy Logistics Database – Addressing Flaws and Suggesting Improvements
• Several Articles and Essays about Legal Subjects Related to Pharmaceutical Topics in Portuguese Pharmacy Publications

cristinafalcaofalcao@gmail.com

http://pt.linkedin.com/in/cristinalfalcao

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