Research & Development
At Helix, the research & development team is dedicated to focus on two areas:
NPD
Process improvement of current products
Our well dedicated program is successful in bringing “first to market – NCEs”, as well as in identifying inefficiencies in the existing formulations by developing better compliant, cost effective process, new technologies in the currently manufactured products.
NPD program follows very scientific methodologies, guided by ICH and covers all aspect of the development from COA of the API to the final.
The New Product Development (NPD) department is committed to developing pharmaceutical products in compliance with ICH guidelines Q8, Q9, and Q10, applying a systematic Quality by Design (QbD) approach to ensure product safety, efficacy, and robustness throughout the lifecycle. Product development is initiated following a comprehensive literature review and pre-formulation studies, including the evaluation of physicochemical properties, biopharmaceutical characteristics (such as BCS classification, solubility, and permeability), and drug-excipient compatibility. In alignment with ICH Q8, the Quality Target Product Profile (QTPP) is defined and Critical Quality Attributes (CQAS), Critical Material Attributes (CMAS), and Critical Process Parameters (CPPs) are identified. A Design Space is then established through multivariate analysis and process optimization.
All development activities are carried out using a risk-based scientific approach in accordance with ICH Q9, utilizing Quality Risk Management (QRM) tools such as Failure Mode and Effects Analysis (FMEA) and Risk Ranking and Filtering to proactively identify, assess, and mitigate potential quality risks. Furthermore, all activities are governed under a formal Change Control system as per ICH Q10, which ensures compliance through a robust Pharmaceutical Quality System (PQS) incorporating knowledge management, Corrective and Preventive Actions (CAPA), management review, and Continuous Process Verification (CPV) for consistent product quality and regulatory conformity. This integrated framework facilitates lifecycle management and enhances process understanding, enabling regulatory flexibility based on scientific justification.
For existing product improvements, a systematic root cause investigation is carried out to scientifically evaluate any product or process-related deviation. Based on literature support and evaluation of formulation and process parameters, the problem is resolved by scientifically optimizing the critical variables to meet the predefined CQAs. Appropriate risk mitigation strategies and process optimization tools are employed in line with ICH guidelines to ensure sustained product quality and performance.