EU-GMP Compliant & WHO-GMP Certified Facility

Quality Policy & Assurance

Quality Policy

Surge Pharmatake considerable pride in developing, sustaining unsurpassed level of quality in manufacturing of drug formulation in order to customer satisfaction.

We are committed to our customers and focus on the quality of our products to the best interests of the patients and the customers.Primary Goal of Surge Pharma is to achieve highest standard of quality of the products.Improving a quality mindset is a continuous process with the involvement of each employee.

Quality understanding and competency will be secured through a comprehensive training system.Surge Pharma aims at being a responsive quality supplier of pharmaceutical finished products in compliance with the current guidelines for Good Manufacturing Practice (GMP).Surge Pharma’s management has a dedicated responsibility for adapting and continuously improvement our quality system. Proactively seek customer feedback and appropriately address them.

Quality Assurance

Commitment to Excellence in Quality

At Surge Pharmaceuticals, our Quality Unit emphasizes science-based and risk-based approaches in product development, fostering continuous improvement throughout the product lifecycle. This proactive approach ensures that our processes and products remain aligned with the latest advancements in quality and regulatory standards.

We are dedicated to exceeding customer expectations by leveraging a highly skilled and motivated workforce. Our commitment is to deliver products of the highest standards by adhering to SISPQE principles (Strength, Identity, Safety, Purity, Quality, Efficacy). This is achieved through ongoing employee training programs and strict adherence to a robust quality management system.

Our team consistently embraces new technologies and applies knowledge gained from commercial manufacturing through statistical evaluation and risk-based Quality Risk Management (QRM) principles. Both prospective and retrospective evaluations are conducted to enhance process performance and elevate cGMP standards.

Our key focus is on ensuring timely delivery of products without compromising quality. This is achieved through rigorous quality control processes and adherence to evolving regulatory standards. We maintain a culture of accountability and improvement by conducting periodic reviews with senior management, ensuring strategic alignment with the latest industry practices.
By embedding continual improvement into our quality system, we reaffirm our commitment to delivering safe, effective, and reliable healthcare solutions that meet and exceed global regulatory expectations.

Regulatory Affairs

  • Our Regulatory Affairs team brings over 15 years of extensive experience in navigating and ensuring compliance with the regulatory requirements of global markets.
  • The team is well-versed in the regulatory guidelines of major health authorities, including USFDA, UK MHRA, EMEA, TGA, and Health Canada, ensuring seamless market entry and compliance.
  • Our Regulatory Affairs team is proficient in compiling and submitting regulatory dossiers, including ANDA, ACTD, and eCTD formats, ensuring accuracy and alignment with global standards.
  • The team possesses deep expertise in product registration in Europe, utilizing National, CMS, RMS, and MRP procedures to navigate the complexities of European regulatory frameworks.
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