APCER Life Sciences: Enabling Organizations to Operate in Compliance with Industry Regulations

While patient safety has always been of paramount importance for regulators globally, the growing trend of collaboration between these bodies has made it imperative for those in the vertical of pharmaceuticals and life sciences to be in complete compliance with the prescribed guidelines for the development and documentation of drugs, clinical trials and more. Moreover, with regulators making it a point to visit manufacturing plants and trial centres, companies can no longer risk any lapse. However, with a number of complex regulations, keeping up with the nitty-gritty details in addition to core business activities can prove to be a daunting task for organizations.

This is where APCER Life Sciences emerges as a lifesaver, enabling organizations to operate in line with the set standards. A dominant player in the pharmacovigilance industry, APCER equips those in life sciences and pharmaceuticals space, clinical research and medical devices space with assurance services, regulatory services, safety reporting, and more. The company also delivers qualityas-a-service along with IT platformas-a-service as a part of its pharmacovigilance services. Kunwar Arora, APCER’s Global COO and MD, India who is a technocrat with over three decades of experience behind him delineates, “APCER is positioned as a knowledge organization, where more than 15 percent medical doctors make up the company’s workforce. These are specialists that cover most therapeutic areas and guide the pharmaceutical organizations through every case, ensuring objective evaluation and accurate reporting. The other 85 percent of the workforce is built of some of the brightest Pharm.D's, M. Pharm's and B.Pharm's.”

Led by Healthcare Professionals
With a workforce consisting of experts in Oncology, Cardiovascular, Neuropsychiatry, Metabolic, Immuno-inflammatory, Musculoskeletal, Respiratory and various other infectious diseases, medical information is yet another area where APCER stands above the rest. The company’s Integrated Response Centers (IRCs) are available 24x7 across the world with multi-lingual capabilities that ensure consistent communication with physicians, pharmacists, patients, site investigators etc along with a quick response to AEs and inquiries/complaints regarding products and services. APCER also facilitates sample retrieval for PQCs and provides written responses, medical information, letters, and FAQs.
The technology solutions delivered by APCER are amongst the latest in the industry and are completely secure and compliant. With automation, digital, innovation/co-creation at its core, these cost-efficient solutions facilitate clients with features that support on-time submissions, quality-rich reports while keeping the focus on patient safety. Secured by two-factor authentication, customers can either choose to operate the platforms on their database or APCER’s database. Recently, the company partnered and launched integrated technology and pharmacovigilance services platform on cloud (powered by cognitive intelligence) that plugs in one of the most critical PV compliance gaps of the pharma industry with proven gold blueprint from 40+ organizations and regulatory bodies in 160 countries.

APCER is positioned as a knowledge organization, where more than 15 percent medical doctors make up the company’s workforce

Successful Track Record
With over 65 long-term global customers, two-thirds of the company's clientele is made up of US-based organizations followed by Europe and then India. Over the years, the company, as well as its customers, have been subjected to inspections and audits, through which they have emerged triumphant. Identifying APCER’s culture as one that is performance-based, Kunwar Arora shares that the team has dedicated itself to establish the company as a leader in the Pharmacovigilance space. In another venture, as a part of its expansion, APCER is launching a state of the art medical information centre in Ahmadabad -as an extension to its centers in New Jersey and New Delhi to address growth that it is experiencing from its global customers.