Pharma Regulatory Consulting
At QAEC Limited, we specialise in providing top-tier quality and regulatory consultancy services to pharmaceutical companies worldwide. We help ensure that your products meet the stringent regulatory standards required for global market access. From regulatory submissions to quality management systems (QMS), we help you navigate complex requirements and streamline your path to compliance.
Our Services
- Regulatory Strategy & Submissions: Guidance on FDA, EMA (European Medicines Agency), and international regulatory pathways, ensuring efficient approval processes.
- Quality Management Systems (QMS): Development, implementation, and auditing of QMS in line with GMP and other global standards.
- Regulatory Gap Analysis: Identifying and addressing compliance gaps for smoother regulatory assessment audits.
- Clinical Trials Support: Ensuring adherence to Good Clinical Practice (GCP) for trials and clinical evaluations.
- Post-Market Compliance: Ongoing support for pharmacovigilance, post-market surveillance, and regulatory safety updates.
Why Choose Us?
- Proven expertise in pharmaceutical regulatory and quality compliance
- Tailored solutions to meet the unique needs of your business
- Up-to-date knowledge of global regulations, including FDA, EMA (European Medicines Agency), and ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines
- End-to-end project support from development to post-market compliance
Contact us today at +44 (0)1452 341913 or enquiries@qaeclimited.co.uk to ensure your pharmaceutical products meet global regulatory requirements and maintain the highest standards of quality and safety.
LET’S CONNECT
If you would like to find out more about our range of services or have a question you would like to ask us, we are here to help.
