`
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.
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.
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.
Optimize Your PV Operations with Insights-Driven Compliance Governance
The Future of PVOPs Management
Compier is a process orchestration and compliance governance solution to streamline, track and manage different PV operations and cross-functional activities involving Market Authorization Holder, Business Partners, Affiliates and Vendors.
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 [...]
