Swaroop Tech

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  • info@swarooptech.com
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CONSULTING

The pharma industry is at the forefront by increasing its market for quality products. However, the industry is constantly evolving forcing the companies to rethink their strategies to build quality products all the while reducing costs. Swaroop Tech Services Pvt. Ltd offers consultancy services to organizations that are challenged by developing the best quality, low cost, and quick delivery of their new or existing products/processes. We have a team of consultants with over 20 years of successful experience in various fields in pharmaceutical companies across the nation. We have a deep understanding of the market and the regulatory issues faced by companies in India and the global markets, thus providing strategic and operational guidance to help companies achieve their goal for growth and profitability.

Our expert team can help pharma companies increase their professional value through our advice on strategic, cost-effective, and innovative product development planning system setups for cGMP according to the world regulatory authority guidelines as well as GMP compliance. We help with plant design to GMP approval by any regulatory agency worldwide.

 

We also provide support by giving post submission query responses and the expert’s opinion on the same and technical advice to scale up and tech transfer projects for finished formulations, various dosage forms, and legal services.
Our consultancy services include regulatory affairs consulting, product development, and analytical and QA consulting.

Regulatory Affair Consulting

Our regulatory affairs consultants help companies to plan and manage their pharmaceutical and medical product development programs and regulatory requirements. The qualified experts can provide consulting advice from the early pre-IND/pre-CTA/pre-IDE stage of pharmaceutical development through to product deployment. We help with dossier/submission preparation or review and filing, post-filing submissions, and pre-meeting packages. Development of a regulatory strategy for the product’s life cycle, meeting international filings, revision of plans as guidelines change, facilitate interaction with regulatory agencies, such as in meetings and conference calls, submissions and approval process, negotiations during development stages, regulatory classification of products across different jurisdictions, provide expert regulatory CMC compliance advice throughout development, and assist with due diligence activities for investors/licensees.

Product Development Consulting

Swaroop Tech can help your company formulate product development strategies for pharmaceutical products meeting international standards, non-clinical studies required for the next phase of clinical development, manufacturing and control issues faced by the companies such as formulation changes, timing, and the requirement for regulatory submissions to support ongoing development activities, manage non-clinical programs and quality components and facilitate clinical programs to support registrations worldwide.

Analytics and QA Consulting

Our consulting programs are designed to meet specific client requirements and we provide in-house, on-site at multiple client locations or third part facilities. We provide complete analytical program design, laboratory design & instrumentation, validation planning & design, Data envelopment analysis (DEA), clean room assessment and monitoring, on-site good manufacturing practice (GMP) / good laboratory practice (GLP) training, quality management systems, regulatory affairs, supplier qualification & on-site GMP audits and validation support.

 

Swaroop Tech guides our clients to grow faster and work smarter using design and operational quality approaches that suit their specific requirements and settings. This helps them improve the customer experience and business performance against the rising competition in the industry while reducing costs and maintaining the quality levels of the pharma products.

Swaroop Tech with its extensive network of committed and experienced professionals provide advice and support to organizations in the following areas:
  • Synthetic Drugs
  • Biotechnology products
  • Cost optimization in pharmaceutical formulations and API operations
  • Analytical Research work such as Chromatography, Spectroscopy, etc
  • Creating strategic and time-bound operational plans
  • Help in new product development and product validation
  • Clinical trial design and protocol preparation

If you are looking for pharma consultancy services, get in touch with us today.

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