As global firms are expanding product portfolio into multiple countries at a faster pace, Regulatory Operations needs should be met at higher speed and in a cost effective manner. Hence, MakroCare Launched Regulatory Operations Center of Excellence to support Global BioPharma by giving different capacity building options/models.
MakroCare today announced the opening of a Regulatory Operations Center of Excellence (ROCoE) to support the burgeoning regulatory needs of Global BioPharma companies. The workforce is divided between USA, UK and India.
To accommodate this growth, MakroCare recently opened a new additional office in India and expanded team in New Jersey as part of its expansion plans. This CoE will provide Regulatory Operations, Life Cycle support, CMC/Clinical/Nonclinical Writing, Labeling, Regulatory BPO and Publishing for Global BioPharma . This also will support regulatory advisory and full service dossier management for small and mid-level clients. The strategic location of the office and talent pool available will allow MakroCare to provide Regulatory expertise and resources in different models (FSP, FTE, On-Demand, Strategic Partnering).
Mahesh Malneedi, President mentioned “Following the success of MakroCare’s full service Regulatory offerings, the ROCoE will be able to effectively support functional components of Regulatory Affairs for TOP 100 BioPharma to increase productivity and reduce cost of regulatory life cycle management for clients”.
Furthermore, the CoE team will bring pre-integrated service offerings and regulatory best practices to add value to clients’ processes for greater efficiency. In addition, clients can leverage the breadth and depth of MakroCare’s Regulatory intelligence of the ever changing global Regulatory needs. MakroCare expects the ROCoE staff size to grow up to 250 by 2014.
MakroCare is a USA head quartered multidisciplinary development, consulting and commercialization global firm that supports pharmaceutical, biotechnology, and medical device industries. MakroCare has 5 main divisions – Consulting, CRO, SMO, DDi(Informatics), and Commercialization. Through these focused divisions, it offers global consulting, regulatory affairs, risk management, site selection, patient recruitment, trial management (P II/III and late phase), biometrics, safety/pv, informatics(eClinical products, solutions), medical/scientific affairs, and bpo services. These services are provided from various offices in USA, UK, Europe and Asia under Full Service, FSP and Strategic Partnership models.