Emerging markets has changed the landscape of Pharmaceutical industry and forced companies to realign their business models. Along with opportunities these markets have also posed lot of challenges as the regulatory environment in these countries is very complex. Global regulatory differences and constant changes to Agency submission requirements even in the age of the Common Technical Document and the eCTD, had challenged Regulatory Operations team on submission planning and strategy.
Regulatory Submission Management Overview:
Companies world over have realized, if they have to survive in today’s challenging economic climate, they must have a global strategy in place to target markets. They are now looking to create new revenue streams or supplement existing ones. Selling products in rapidly growing emerging markets (Asia, Latin America, the Middle East, and Africa) presented many opportunities to extend a drug’s lifecycle and profitability.
However opportunities in emerging markets have also brought in many challenges as local regulatory requirements in each country are governed by their regional compulsions. Reason, the regulations were written to safeguard the needs in those countries and the regulations had evolved independently of one another. Consequently, there is an enormous amount of diversity in the regulations, laws, and procedures for registering new pharmaceutical products.
Submission Management hampered by over reliance on Regional Hubs:
Pharmaceutical companies slowly realized that the key to success in these markets largely depended in obtaining timely marketing/clinical approvals from regulators for which local regulatory knowledge had become the key.
The companies were in a fix as they did not know whether they had to “standardize” or “Customize” the application while approaching health authorities for market approval of their products. As there was tremendous regional pull on local requirements, companies were left with no option but to strengthen their regional regulatory departments or outsource to local regulatory affairs consulting firms.
During the years regulatory landscape had changed and companies have moved to building regional hubs and networks. Unfortunately companies did not foresee the growing complexities within their team structure and the lags they were building which went on to become obstacles in their overall structure.
Global Regulatory Submissions: SubSure ‐ the Faster & Compliant Way:
In spite of recent advances companies are still struggling to manage Global Submissions. Lack of optimization in both infrastructure and business processes is making it difficult to take full advantage of business process optimization offered by RIM environment. It’s time for companies to think beyond efficiency by optimizing the RIM environment.
Business Process Mapping:
In most of the companies, departments which are responsible to maintain the product in the market are working in silos, with none of them having sufficient visibility or appreciation of the work other teams putting in, and or having limited knowledge on the impact this has on the overall output of the company.
Planning for a Submission (Eg: Variation) is always a time‐consuming and complex process, more so because Regulatory Teams are challenged on tight submission deadlines and submission of compliant documents. Regulatory function can support organizational growth provided if it no longer looks function‐by function and process‐by‐process.
Author Bio: MakroCare help you solve the Regulatory Strategy, Writing, and Submissions Management with innovative and customized solutions. We have a strong team of dedicated professionals with many years of industry and agency experience, who can tailor the project plans to meet different regulatory requirements.
Keywords: Electronic Submissions, eCTD Submissions, Regulatory Submissions, FDA Regulatory Submissions, Regulatory Submissions Expert, Regulatory affairs submissions expert, Regulatory Submissions Process , Regulatory Submissions Associates.