| Regulatory Affairs Outsourcing | | | | unless there is active participation of the |
| Regulatory Affairs Unit in a pharmaceutical | | | | customer (party hiring the regulatory firm). |
| company is a vital unit that drives the R & D | | | | Once it is established the service offered by |
| efforts of the company to the market | | | | regulatory affairs professional can help company |
| successfully. Today a Regulatory Affairs | | | | save both time and money, proper selection of |
| department is a dynamic business unit which | | | | regulatory professional is very important. This |
| works with a focus to get products to the | | | | article will explore some of the key points for |
| market with a commercially viable label in the | | | | selecting a regulatory affairs consultant |
| least possible time and expenses. | | | | Experience: Experience in pharmaceutical industry |
| Today the world has become a global village and | | | | particularly in drug development is an essential for |
| many companies are in a race to place many new | | | | pharmaceutical regulatory consultants. Consultants |
| products in the world markets to gain market | | | | should have experience in preparation and |
| share and increase earnings. In such a scenario a | | | | submission of regulatory documents. A consultant |
| small delay in gaining market access means huge | | | | working actively in this field for 5 -10 years will |
| loss in terms of market share and revenue | | | | have extensive knowledge on getting approval for |
| generated. The key to success for pharmaceutical | | | | various drugs, he will be able to formulate |
| companies lies in obtaining timely marketing | | | | regulatory strategies and implement them. His |
| approval from regulators. | | | | professional references, documents prepared by |
| So to obtain timely marketing approval companies | | | | him, approvals obtained by him, articles published |
| can either strengthen then regulatory department | | | | by him can be used to evaluate his experience. |
| or outsource the same to regulatory affairs | | | | Confidentiality: A Confidentiality agreement has to |
| consulting firm. | | | | be in place to protect your company’s |
| With changing global regulatory norms, outsourcing | | | | proprietary knowledge. A consultant’s |
| regulatory affairs work seems a more beneficial | | | | confidentiality can be evaluated by requesting |
| option both in terms of time and money. | | | | previous studies and information shared can be |
| Maintaining a large regulatory affairs department | | | | used to judge the same. |
| can be very expensive and scope of knowledge | | | | Staff: A company must have adequate staff to |
| can be limited to certain aspects. On the other | | | | serve ongoing projects without delay. The staff |
| hand a regulatory affairs consultant keeps on | | | | must be highly skilled and trained to carry out |
| updating himself with the current regulation and | | | | regulatory work. Staffing capability can be judged |
| has vital experience in the field to expedite the | | | | by visiting the consultant’s office, professional |
| approval process. | | | | associations, website information and office |
| This article further explores the services provided | | | | locations. |
| by regulatory affairs professional and the key | | | | Collaborations: The Company must have access |
| points for proper selection. | | | | to key technical and scientificresources at their |
| There are many regulatory affairs consulting firm | | | | disposal for timely completion which can be |
| providing services both at a large scale and small | | | | achieve by having in house facility or collaboration |
| scale. Large scale service provider’s posses | | | | with other service providers. |
| large ranges of expertise under one roof, operate | | | | System: Company should have in place standard |
| on a global basis, some even have local presences | | | | system to carry out the work effectively. Initial |
| in different countries. While small regulatory firms | | | | communication with the company will give an |
| specialize in one or the other aspect of regulatory | | | | impression of how far the company is organized |
| affairs, for e.g. compiling dossiers, Analysis, agency | | | | and follows a standard system. |
| contacts etc. | | | | Technology: Technology has become a key part |
| Well established regulatory firms can provide | | | | for success and timely submission today. With the |
| service in the following ways | | | | introduction of eCTD it has become important for |
| • Compiling large regulatory application for | | | | companies to integrate technology in their |
| submission in different countries | | | | companies. Website of the company can be an |
| • Expertise Knowledge regulatory and | | | | example of adoption of technology. |
| scientific knowledge | | | | There are many more criteria which can be used |
| • Expertise knowledge and support in | | | | to evaluate and select proper regulatory affairs |
| terms of local regulatory authority | | | | consultant but this article is limited to the above |
| • Expert solutions to FDA queries | | | | mentioned criteria only. |
| • Access to Scientific and technical | | | | Regulatory affairs outsourcing is on a growth |
| resources | | | | worldwide, many large and small companies have |
| • Formulation and implementation of | | | | adopted this strategy to get a timely approval. |
| regulatory strategies on a global level | | | | Even multinational firms are outsourcing their |
| A regulatory firm can sure accelerate the | | | | regulatory work to lessen the pressure on their in |
| submission process, but this won’t happen | | | | house team or to support the same. |