Patients rely on medicines and medical devices being safe, efficacious and of high quality. To ensure this, health authorities have put forward strict regulation that must be fulfilled when developing and manufacturing such products. Often the regulation is supplemented with regulatory guidelines providing more detailed guidance. The regulation and guidelines can be different across markets such as US, EU, Japan and China. You need to ensure you have access to people having both detailed country specific knowledge of the regulation/guidelines and industry experience.
Spot-on Pharma Consulting can help you within below areas:
Training in GMP according to your needs
Perform internal and external audits
Support you before, during and after a GMP inspection
Advice you on specific GMP challenges
Preparation of global Quality strategy that is aligned with manufacturing, R&D and other important stakeholders
Act as project manager for various projects according to customer needs
Act as interim manager for the Quality function
Combining lean tools and domain expertise to make simplified processes which are GMP compliant and ready for digitalisation
Establish QMS covering R&D, manufacturing and affiliates
Act as Qualified Person (QP) and perform batch release
Act as Responsible Person (RP) in accordance with GDP requirements
Evaluation of target company’s QMS including review of key documentation to assist investor in decision making
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