Optimizing Pharmaceutical API Processes
Explore how our systemic approach to API processes yielded close to 100% reduction of API content variation and a reduction of batch scrap rate from 40% to 10%.
GOOD STORIES
When a US-based pharmaceutical startup needed to move their lead candidate from the research phase to product development, which involved increased regulatory requirements, they turned to Emendo R&D for assistance. Our team built a Customized Quality Management System (QMS) tailored to the company’s specific needs while supporting the establishment of a quality culture within the company.
THE CHALLENGE
For many pharmaceutical startup companies, entering the GxP regulated phases of product development is challenging due to the complexities of ensuring compliance with regulatory standards such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) as well as establishing a suitable level of documentation.
Documented compliance already from the early stages of development must be included in the Regulatory Submission (MAA/BLA) when the drug candidate, hopefully successfully, reaches the end of phase III clinical trials. Getting it right from the beginning saves time and effort in the end no matter if the development is done in partnership or by the biotech themselves.
Moving from a dynamic, research-oriented approach to this more regulated framework, which is characterized by a heightened emphasis on documentation, represented a significant paradigm shift for the company. They faced the task of not only implementing new processes but also fostering a quality culture within the organization to navigate the GxP regulatory demands.
OUR APPROACH
The challenge was multifaceted, requiring the R&D team to address both technical and cultural aspects of compliance.
Using our QMS maturity model, we analyzed the current quality level, development stages, and existing processes. Key areas were identified for alignment with GxP regulatory requirements. As a “fully outsourcing” company, it was crucial the QMS fit this business model.
We tailored the QMS to meet business needs, internal systems, and workflows — applying the same structured mindset we used in this API manufacturing project to drive compliant and efficient pharmaceutical development. This provided structured procedures and a customized approach to documentation, compliance, and quality assurance.
OUR APPROACH
We worked closely with the company during the implementation phase of the new QMS. Our team provided training to employees at all levels, equipping them with the necessary skills to navigate the system, understand their roles, and appreciate the importance of adhering to regulatory requirements in the following phases of development.
By fostering a mindset focused on documentation and well-considered decision-making, we aimed to create a foundation for excellence in the company’s pharmaceutical development.
THE RESULTS
The tailored QMS and focus on quality culture helped the company navigate challenges in regulated product development phases. They addressed increased regulatory requirements on time and established a solid foundation for quality compliance. This will benefit the company, patients, and future development partners.
The company’s journey with Emendo R&D proves the effectiveness of a customized QMS solution. It meets regulatory requirements and aligns with the needs of a pharmaceutical startup. Our partnership shows how organizations can thrive in regulated environments while staying committed to innovation and patient safety.
GET IN TOUCH
Our Pharmaceutical Development team specializes in tailoring solutions with our R&D excellence approach, combining expertise and know-how within advisory, development support, and Quality.
Reach out to Britt Dam Raaby, Vice President at Emendo Research & Development, to explore your path forward.
HAVE A QUESTION
A Quality Management System (QMS) in pharmaceuticals is a structured framework of processes, procedures, and documentation that ensures a drug product’s quality, safety, and regulatory compliance throughout its lifecycle. It covers areas such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
A customized QMS helps pharmaceutical startups transition from research-focused methods to GxP-compliant processes essential for product development and regulatory approval. Tailoring the QMS ensures it aligns with the company’s size, outsourcing model, and operational needs without adding unnecessary complexity.
Key components include:
Implementing a QMS ensures that all necessary documentation and compliance records are in place from the early development stages. This supports faster and smoother regulatory submissions such as Marketing Authorization Applications (MAA) or Biologics License Applications (BLA) by meeting FDA, EMA, and other regulatory body requirements.
A strong quality culture ensures that all employees understand the importance of compliance, documentation, and decision-making based on regulatory standards. This mindset reduces errors, supports continuous improvement, enhances trust with partners and regulators, and ultimately protects patient safety.
