P: David Priestley

MSc CChem MRSC

M2M Regulatory Consultants Ltd

David set up M2M Regulatory Consultants Ltd in 2005 after acquiring extensive regulatory experience from roles in government, industry, trade association and with a specialist regulatory CRO. His particular skills are in supporting early product development and transition from preclinical to clinical phases and due diligence activities, with particular expertise in regulatory CMC requirements and clinical development of products in oncology and immunology.

M2M Regulatory Consultants Ltd offer the following bespoke services to the Pharma/Biotech sector:

  • Complete product life cycle regulatory affairs support, with specialisation in the early drug development/clinical phases
  • Strategic drug development and regulatory affairs
  • Clinical Trial and Marketing Authorisation support
Expand Skills Show Skills
Country experience

UK

Professional affiliation

MTOPRA

RSC

Expertise area

Biocides

Borderline product issues (biocides, drug+device)

Clinical trial applications (EU, USA, Canada)

Due diligence

Expert summaries

Export certificates (CPPs)

FDA NDAs

Investigational Medicinal Product Dossiers (IMPDs)

Marketing authorisation applications (MAAs)

Pesticides

Orphan medicinal products

Pharmaceuticals

Product development

Regulatory and environmental

Training

Variations, renewals, SPC and Labelling issues

Company (as employee)

GMG Biobusiness Ltd

Janssen-Cilag

Millenium Pharmaceuticals UK Ltd

Pharmacia

UK Dept of Environment

Knowledge area

Cardiovascular

CNS

Dermatology

EU legislation

Haematology

Inflammatory and metabolic diseases

Oncology

Veterinary products

Contact Details

Keyword Search:


 

Areas of expertise: