Ethix Pharma: Strengthening Medico-Regulatory Services across the Country

CIO Vendor The global medico-regulatory affairs outsourcing market was valued at $ 1.9 billion in 2014 and is expected to reach $ 5.7 billion by 2023, at a CAGR of 11.5 percent during the forecast period from 2015 to 2023 (Source - Transparency Market Research forecast 2015-2023). In recent years innovator companies are increasingly relying on the CROs not only for clinical trials but for other specialized activities in drug development process. Biopharmaceutical companies are now outsourcing their medico-regulatory requirements in order to access new capabilities of CROs, focusing on core competencies and variable costs. As most of the global CROs established their operations in north, west or southern parts of India, the central India becomes a virgin destination to offer Pharma–bio services. Tapping to the geographical advantage, connectivity, growth potential of central India, Ethix Pharma emerged as an only full service CRO within the region.

Ethix Pharma founded in late 2009; is an independent global CRO contracted by the sponsor’s for regulatory, clinical operations and specialized non-clinical studies. Global regulatory services include core competencies in the field of Extended Eudra Vigilance Medical Product Dictionary (XEVMPD) compliance with Article 57 in EU. Medico marketing, risk based monitoring and clinical expert statements for safety update reports in Pharma covigilance. These services are offered to Pharma-bio, chemical, agro chemical, nutraceutical and food sector companies to be compliant to their R&D programmes for new molecular entities (NME’s), generics (ANDA’s), over the counter (OTC’s), Botanical drug products (BDP’s), Neutrceutical, Dietary supplements (DS), Novel Food and additives (NF) products globally. More than a decade experienced medico-regulatory subject matter experts, trained high performance team and robust IT enabled systems intelligence, positions Ethix Pharma as preferred global strategic consulting partner. “Resourcing is the new outsourcing” says Yogendra Choudhary, Founder; Ethix Pharma. The company believes in adding exponential value to the client R&D life cycle management and successfully adheres to drive it through its diversified functional portfolio of capabilities and expertise in global regulatory insights for compliance.

Of late clinical development programs are facing more pressure than ever to reduce costs while maintaining quality and improving operational efficiency. Mergers and acquisitions, outsourcing, down sizing and strategic alliances have become the new normal. As a result, sponsors are rethinking their operating models. The new clinical development operating model must be a resource-driven partnership. Achieving alignment of strategic and operational goals with partners continues to be among the greatest challenges that sponsor face. “To achieve this means embracing a new strategic operating model – CMO. A CMO is a non conventional service approach by Ethix Pharma with sponsors committed to a common set of strategic and operational business objectives; supported by integrated business processes and technologies that enable real-time collaboration; capable of providing consistent performance, regardless of time zone, location, department or company affiliation,” explains Yogendra.

Ethix Pharma team consists of experienced medical and regulatory consultants, clinical, Lifesciences, Pharma experts and medical writing professionals providing robust solutions in medico-regulatory space

Similarly the PV legislation was published in Dec 2010, in which Article 57(2) defined that for the purposes of Eudra Vigilance a list was to be created of medicinal products for human use authorized in the EU by 2 July 2012. Establishing resources and budgets was challenging for most companies as it was unanticipated work which required resources to prepare and submit the data. Most companies didn’t have all of the info readily available, even those that had previously submitted the optional info. In many companies there was a lack of expertise and there was a need to rapidly understand the hundreds of pages of guidance. Project management was clearly needed within many companies to support the scale of the activity with in the intended time scales. “Ethix Pharma ISO IDMP regulatory team had defined operational efficiency to plan the data capture, data clean-up and to define processes and technology support, get registered in the EMA’s Eudra Vigilance environment, undertake training, many other tasks besides and assisted companies in EU to become complaint to the legislation,” explains Vandana Co-Founder; Ethix Pharma.

Ethix Pharma team consists of experienced medical and regulatory consultants, clinical, Life sciences, Pharma experts and medical writing professionals providing robust solutions in medico-regulatory space. The major factors that have contributed for a successful and long journey of Ethix Pharma were; the transparent practice of consulting, the nature of assignments we had undertaken; the value we generated for our clients, and the way our consulting firm was organized and managed.

Ethix Pharma has three core service modules, classified as Discovery Biology, Clinical Research and Medico-Regulatory. The company has various validated research models in discovery biology in more than 15 therapeutic areas via its research partnership. The clinical operation team is having niche expertise in Risk based monitoring and active clinical partnership with promising sites in India and abroad. The Medico-regulatory extension helps in EU-PV and ISO IDMP compliance as a specialized service.

Ethix Pharma is in an expansion mode today. They are positioning themselves to offer localized support and strategic working partnership to the established Ethix Pharma consultancies based in Malaysia, UK and Canada, and to grow to become the pioneers in the field of Medico-regulatory consulting and in India over the next 3-5 years. In addition to strengthen their organized and robust quality management service; the company aims to provide high-quality training and talent development programme in core areas of XEVMPD, Pharma covigilance and Risk based monitoring with premier institution and government agencies in India and overseas over the next 2-3 years.

Ethix Pharma’s approach to tactical service offering emphasises on resource alignment, connecting operational model (COM) and XEVMPD expertise in EU are the core differentiator for a robust project consulting has helped Ethix Pharma carve a niche for itself in the industry.