Available Services

Our expertise extends across a broad spectrum of pharmaceutical and medical device manufacturing, encompassing validation of equipment used in the processing of Oral Solid Dosage (OSD) forms, biologics within the life sciences sector, small molecule drugs, combination devices, and standalone medical devices. We understand the unique regulatory requirements and validation challenges associated with each of these areas and tailor our services accordingly.

We have partnered with life science companies to develop robust and compliant validation plans tailored to their specific needs. Our multi-faceted expertise allows us to address the unique regulatory challenges of the industry, ensuring your validation strategy meets all applicable requirements and facilitates the successful development and commercialization of your products.

We possess deep expertise in the validation of software systems critical to pharmaceutical operations, including Laboratory Information Management Systems (LIMS), Enterprise Resource Planning (ERP) systems, Quality Management Systems (QMS), Manufacturing Execution Systems (MES), software embedded in lab equipment, process equipment, and Building Management Systems (BMS), etc.. Our comprehensive understanding of GAMP 5 principles and regulatory requirements ensures that your software validation processes are robust, compliant, and contribute to the overall quality and integrity of your pharmaceutical products.

Our facilities validation expertise encompasses critical systems such as HVAC (Heating, Ventilation, and Air Conditioning), utilities, etc. ensuring they meet the stringent regulatory requirements of the pharmaceutical and life sciences industries. We understand the importance of controlled environments in these sectors and provide comprehensive validation services to guarantee the proper functioning and compliance of your facilities.

Our process validation expertise covers the manufacturing of a diverse range of products, including Oral Solid Dosage (OSD) forms, biologics within the life sciences sector, small molecule drugs, combination devices, and medical devices. We understand the intricacies of each manufacturing process and apply a comprehensive, risk-based approach to validation, ensuring compliance with regulatory requirements and the consistent production of high-quality products.

Our expertise in cleaning validation ensures that your manufacturing processes effectively remove residues and contaminants, meeting stringent regulatory requirements and safeguarding product quality. We develop and execute comprehensive cleaning validation programs, including method development, validation protocols, and ongoing monitoring, to guarantee the consistent cleanliness of your equipment and manufacturing environment.