Vasishtha Mehta, Founder & Managing Director

Vagmin Mehta, Director - Corporate Communication

Indian Pharma Industry has been on the rise since ear­ly 1990s and driven majorly by government initiatives such as Make in India, PLI, 100 percent FDI, and PRIP, India has strongly cemented its position as a global phar­ma manufacturing hub in recent times. Already renowned globally for their research and technical capabilities, Indian pharma manufacturers are now eyeing the bigger fish dominating the global market. But given the stringent global quality standards that are to be maintained in order to export their products abroad, pharma companies are now laying prime emphasis on implementing industry-best practices across the entire drug development value chain. However, this is easier said than done and requires vast knowledge of the pharma business and the related regula­tory landscape as well.

Emerging as the life savers in this regard are GxP consultants such as Anthem GxP Solutions Pvt. Ltd., who through their vast industry knowhow, are handholding pharma companies to successfully navigate compliance related affairs. Based in Ahmedabad, Anthem was incepted in 2010 by Vasishtha Mehta (Founder & Managing Director) who possesses over 38 years of rich experience in the automation and compliance arena. Standing as a strong pillar of support for the company is his son Vagmin Mehta (Director – Corporate Communication), the 25-years young Computer Engineer who joined Anthem GxP Solutions in 2020 and is already handling numerous project sites as well as compliance audits on his own.

“Of late, we're witnessing the emergence of advanced digital technologies such as connected systems, cloud and AI/ML into the compliance vertical. On the other hand, there has also been an increased awareness among regulators as well as manufacturing and research companies around data integrity and compliance benefits. Thus, as technologies continue to evolve, the compliance landscape too will become more complex and stringent in the days to come”, says Vasishtha.

One-stop Solution Provider

Under the able guidance of the father-son duo, Anthem GxP Solutions has positioned itself as a one-stop destination for diverse compliance requirements. The company offers services majorly under four categories, namely Compliance & Computer System Validation, Spreadsheet Validation & Optimization, Training and Audit. Compliance & Computer System Validation being its key forte, some of the major services that it offers include Process Control (PLC/SCADA/BMS) System Validation, Software (ERP/ SAP) Validation, Laboratory Computerized System Validation, IT Infrastructure Qualification, Test Protocols Preparation, Periodic Review & Audit Support, and Vendor Assessment. These services not only optimize compliance and regulatory requirements for the clients, but also ensure that their computer systems remain capable of producing pharmaceutical products without compromising on quality, efficacy, patient safety, or electronic records integrity.

From pharmaceutical manufacturing systems such as PLCs and SCADAs, to information management systems, laboratory systems (HPLCs, GCs and FTIRs), quality systems and business/enterprise systems, Anthem GxP Solutions' services encompass the entire spectrum of software and computer systems that the pharma industry uses. A pivotal factor that has helped the company maintain such diverse services its highly experienced team of engineers and pharmacists who are well versed in US FDA, 21 CFR Part 11, EU Annexure 11 requirements and follows internationally accepted GAMP-5 guidelines & its current interpretations.

Client-centricity at its Core

Keeping customer satisfaction as paramount, Anthem GxP Solutions first gets a clear understanding of the client’s systems or project, gets all the URS (user requirement specification) from them, suggests the areas within their systems that they might have overlooked or need improvement, and only then recommends the kind of intervention that might be required to maintain cGMP compliance. Additionally, for every new client that’s being on boarded, Anthem GxP Solutions ensures that a senior member of its team with at least 5-10 years of experience is involved with them as a brand ambassador or POC. Along with building a good rapport with the customer, this person also conducts periodic meeting with them, submits reports about the progress of the project, and even informs them if there are any unforeseen delays or problems. This has helped the company immensely in building trust and transparency with its clients, which are qualities that have often brought-in repeat business and word-of-mouth publicity for Anthem GxP Solutions.

“Right from definition of the project to the complete documentation, we ensure that the client is happy not only from the documentation or compliance support that we provide, but also with our people who visit their sites as part of the project. Be it PLC, SAP or any other system, the level of testing that we do, the ingress that we take care of as a part of documentation, and finally, the delivery & customer rapport that we maintain have been the stand-out factors for us in the market”, Vasishtha further explains.

Passing-on the Flame of Excellence

Anthem GxP Solutions has managed to achieve a strong foothold across India, Middle East, Bangladesh, Europe and US markets, along with a 10-15 percent increase in its clients each year. Some of the major clients that it caters to include Torrent Pharmaceuticals, Indoco Remedies, Themis Medicare, Alembic Limited to name a few. Having come on board recently in 2020 and already making strong strides as the company’s next flagbearer, Vagmin and Vasishtha have together chalked-out strong plans for Anthem GxP Solutions.

Currently focused majorly on design, implementation, validation, compliance and assurance areas, going forward, the company envisions foraying into product development as well and come-up with up with a software product for compliance vertical. With basic specification already drafted and hiring underway for the development team, the first product is expected is expected to be ready in a year and be launched into market the following quarter.

“MES is yet another area that we’ll be focusing on in the coming days and are already tying-up with top line manufacturers and suppliers. This way, over the next 3-6 months, we envision positioning ourselves as a technology, implementation, design, compliance and assurance company capable of efficiently handling even the high-end projects. However, core GMP software will remain our primary focus area for our development and as part of the support system”, says Vagmin, the dynamic youngster under whose leadership Anthem GxP Solutions will no doubt scale new heights and emerge as one of the most sought-after compliance & validation partners in the days to come.