Friday, 24 October 2014

Medical writing and Regulatory Affairs from WorkSure

WorkSure A First Medical Service KPO in India is a consultancy organization providing services to Healthcare companies within the Regulatory Solutions, Technical, Medical Affairs, Phamacovigilance and other fields. WorkSure is highly skilled and offers strategic and operation experience combined with company know-how and its strategies, ensuring the rapid fulfillment of excellent results.
The services range from regulatory affairs to preclinical and clinical scientific research, statistical solutions etc. WorkSure ensures efficient support across all areas like medical writing and procedural assistance during the life-cycle of products. WorkSure can also help in editing and review of sponsor prepared documents, SOP preparation and from bio-pharmaceutical studies to initial phases of clinical testing.
WorkSure direct interaction with Regulatory Affairs, Technical Production, Medical and Marketing Departments ensures high level competence, speed and operation flexibility. Also, they co-operate with the Management and other departments involved in the project to enhance and develop the company portfolio.
Why outsource to WorkSure?

Most companies have adapted the outsourcing strategies that allow maximum flexibility of structuring, minimizing their costs and integrating the company know-how with the skills and capabilities which are specifically hired for individual projects helping management to focus their time, energy and internal resources on strategic activities.
The relationship between the Client and WorkSure is based on trust, mutual understanding as well as working professionalism and the SOP’s we follow. Once the relationship is established, the Client can rely on a professional outsourcing service that is qualified in multiple areas (Regulatory Affairs, Pharmacovilance, Medical Writing, Research Solutions, Pre-clinical and Clinical Trials) and as the need be.

How outsourcing can be a useful activity?

a) You receive trained professionals to do your job without requiring hiring a trained staff or training the internal staff. b) You get the work done from the specialized professionals in strategic areas for the company without require additional resources.
c) Commitments for a limited period and do not require to you recruitment an internal personal.
Worried about certain activities becoming a problem for your company? It is time to consider outsourcing. You decide what you want to outsource and when to do it. WorkSure plays a key role in this respect and can help you plan the most effective service modalities with its experts, in accordance with your needs.
Regulatory Affair Services

WorkSure Regulatory Affairs covers a wide variety of different areas helping companies across the pharma and related industry sectors in helping them manage their daily regulatory affairs along with additional activities which need specific expertise or additional resources. These activities can be partially or fully outsourced.
The primary services include

Medical consultant representation at National Regulatory Authority meetings
Preparation of Clinical Trial Application (CTA), Investigational Medicinal Product Dossier (IMPD), Investigational New Drug (IND) & New Drug Application (NDA)
Render support for preparation of medical device submissions eg 510(k) and pre-market approval documentation.
Risk Management Plan / REMS (Risk Evaluation and Mitigation Strategies) and other regulatory documents for clinical trial and drug marketing approval.
Preparing prescribing information, product monographs and product labeling

The advantage of WorkSure Outsourcing resides in its integrated know-how derived from the experience and knowledge in multiple areas by its staff over the years of work and outsourced projects. This know-how is utilized for the clients by the project leaders who can always count on team work and constant support.

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