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Regulatory Affairs Consulting

Accelerating Innovation, Delivering for Patients

We provide end-to-end regulatory affairs services throughout the entire lifecycle of your medicinal product – from early development clinical trials, through to major agency submissions (NDA, MAA, BLA) and post-approval maintenance.

Our experience covers all types of medicinal products, markets (EU, US, UK and rest of world) and therapeutic areas, involving small molecules, biologicals, biosimilars, branded and generic products. We accelerate innovation through our highly-respected regulatory affairs team, who have decades of experience in delivering regulatory solutions and strategic guidance to a wide portfolio of clients, tackling some of the most technically challenging projects, delivering successful client outcomes that are flexible and cost-effective and that offer exceptional value to clients from both commercial and scientific standpoints.

 

Furthermore, we deliver for patients and keep them at the center of what we do. Whilst performing all of our services, we are conscience of the impact to patients, and this drives us to be the best at what we do.

Our Services

Early Development Clinical Trials

  • Agency meetings, Scientific Advice / Protocol Assistance

  • Advisory Committee meetings & preparation

  • Clinical Trial Filing (CTA and IND)

  • Investigator Brochure / IMPD / IND authoring

  • Risk management planning

  • Early Access Programs, PRIME, Breakthrough Therapy Designation

  • Paediatric Investigation Plans (PIPs), Orphan Designations

  • Expert Advice (Quality)

  • Global Regulatory Intelligence

Marketing Authorisations

  • Authoring of MAA, NDA, BLA, ANDA submissions

  • Full procedure support for US and EU application procedures (National, MRP, DCP, CP)

  • Module 1 preparation

  • Module 2 Quality Overall Summary

  • Module 3 Quality

  • Artwork and Labelling (including Summary of Product Characteristics (SmPC), Company Core Data Sheets (CCDS), Product Information Leaflets (PIL) etc.)

  • Support for pre-submission meetings

  • Local regulatory intelligence and support

  • Response to Agency questions

Lifecycle Management

  • Variations

  • Amendments/supplements

  • Product licence renewals

  • Annual reports

  • Line extensions

  • Artwork and labelling

  • Technical authoring

  • Submission management

  • Expansion into new markets

  • Regulatory intelligence

  • Local submission support

Other CMC Activities

  • Advice and consultancy

  • CMC Gap Analysis

  • Data collection and collation

  • Adjudication

  • Remediation

  • Project management

  • Health Authority communication

  • Manufacturing site rationalization

  • Site transfers

  • Change of ownership

  • Due-diligence and divestment

  • CMC compliance

  • CTD build and conversion projects

Client Case Studies

Expert Experience

Positive Feedback

Our DNA Infographic

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