Quality and Compliance

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:

GMP training

Training in GMP according to your needs

GMP audits

Perform internal and external audits

GMP inspection support

Support you before, during and after a GMP inspection

GMP counselling

Advice you on specific GMP challenges

Quality strategy

Preparation of global Quality strategy that is aligned with manufacturing, R&D and other important stakeholders

Project management

Act as project manager for various projects according to customer needs

Interim management

Act as interim manager for the Quality function

Process simplification

Combining lean tools and domain expertise to make simplified processes which are GMP compliant and ready for digitalisation

Quality Management System (QMS)

Establish QMS covering R&D, manufacturing and affiliates

Batch Release

Act as Qualified Person (QP) and perform batch release

Good Distribution Practice (GDP)

Act as Responsible Person (RP) in accordance with GDP requirements

Due diligence

Evaluation of target company’s QMS including review of key documentation to assist investor in decision making