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Entry to Regulatory
Expert Regulatory Services

Accelerating Innovation  |  Delivering for Patients 

About Us

We are a leading product development and regulatory affairs consulting practice serving the pharmaceutical and biotechnology industry. We are committed problem solvers, redefining the meaning of customer service, with a focus on reducing time-to-market, minimising development costs and ensuring continued supply. We keep our client's needs and the patients who benefit at the heart of what we do.

A combination of scientific excellence, industry experience and a collaborative approach enable us to deliver high-quality innovative solutions, which allow our clients to succeed.

Our team offers strategic and operational support in the fields of CMC and regulatory, which guide products efficiently from early development to marketing approval and post-approval maintenance.

Our Services Include

Regulatory Affairs Consulting

  • Full lifecycle support - from early development clinical trials, through to major agency submissions (MAA, NDA, BLA) and post-approval maintenance.

  • Support for biological, small molecule, branded and generic products.

  • Submission authoring, agency interaction, regulatory strategy, risk mitigation, site transfers and compliance.

  • US, EU, UK and rest of world markets

 

Regulatory Affairs Training Courses​

  • Bespoke in-house training

  • ​Entry courses - junior professionals

  • Excel courses - mid-level professionals

  • Expand courses - senior professionals