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Sectors We Specialize for Pharmaceutical Product Development

Biopharma

Expediting the Development of Biologics and Biosimilars

The successful launch of biologicals and biosimilars requires a diverse patient pool outreach. With the collaboration network we have with hospitals and research institutions, Techsol has the proven capability to finish high-quality clinical trials with uncompromised data.

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MedTech

Trusted Solutions for Medical Devices Clinical Research

For medical devices, Sponsors are deeply concerned on patient safety and that precedes over all other priorities.  At Techsol, we specialize in conducting patient-centric medical device clinical trials with a strong emphasis on risk-benefit evaluation.

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Food & Nutraceuticals

Expertise to Conduct Food and Supplement clinical trials

A third of food and nutraceutical products do not have the evidence to prove half of the health claims. We help companies to conduct clinical studies to determine cause and effect relationships and scientifically demonstrate true product value.

Intelligence Background

Optimize GxP Operations with Insights-Driven Quality Oversight and Compliance Governance

The Future of GxP Operations Management

Compier is a process orchestration and compliance governance solution to streamline, track and manage different GxP operations and cross-functional activities involving Market Authorization Holder, Business Partners, Affiliates and Vendors.

INCREASE PROCESS SPEED AND QUALITY
REDUCE AND ELIMINATE COMPLIANCE RISKS
TAKE RISK-BASED INFORMED DECISIONS
FACILITATE STAKEHOLDER COLLABORATION
ALWAYS STAY AUDIT READY

Explore how Compier fits your strategy to increase your productivity

Accelerate Your Transition to Oracle Argus Safety Cloud Solution

Planning to implement an integrated Drug Safety and Signal Management solution?

As a preferred partner of Oracle, we have a rapid solution delivery method with a validated Argus Safety Cloud platform.

>> What’s New at Techsol

On July 16th, Techsol moved to a new office space at Hyderabad, India. The opening ceremony was inaugurated by Mr. Jayesh Ranjan (IAS), the Principal Secretary for the Government of Telangana. With our continuous team expansion, we are thrilled to work with clients and extend our innovation for the betterment of medical research and healthcare.

>> Our Industry Insights

FDA’s proposed guidance on CSA

The Pharma Industry’s Outlook on FDA’s proposed guidance on Computer Software Assurance (CSA) Background After 20 years since the release of the first guidance document for Computer Systems Validation (CSV), FDA has started to realize that the traditional documentation focused validation process followed for the last two decades will no longer be ideal for assuring [...]

Global Regulatory Changes in Biopharma

Evolution in Global Pharmaceutical Regulatory Landscape & Notable Changes for Sponsors Pharmaceutical companies must comply with regulations set forth by respective regulatory agencies right from the pre-clinical to post-marketing phases of clinical development. Each regional agency has a wide array of stringent guidelines for various processes to ensure patient safety and product quality. With changing [...]

ICH’s eCTD Version 4.0 – Objectives, Major Updates, Resulting Advantages and Possible Challenges

ICH’s eCTD Version 4.0 The Electronic Common Technical Document (eCTD) has become the global standard for electronic submissions in the Life Sciences industry. An eCTD submission has five modules: Region-specific information Summary documents Quality-related information Nonclinical study reports, and Clinical study reports. Most global regulatory agencies such as US FDA (USA), EMA (EU), Health Canada [...]