What we Offer

Regulatory/Quality

Assisting with method scouting
Analytical development
Process development
Project management
Regulatory and agency advice
Non-clinical development support
Clinical development support and trials management
Non-clinical/clinical clerk interpretation
Non-clinical/clinical assessments
Compilation of Marketing Authorisation application and agency submission
Development and training in QA systems
Preparation of documentation (SOPs, reports, licence sections, protocols, development of Validation Master Plans)
Planning and implementing technology transfer
Qualified Person (QP)
Quality Control (QC)
New Product Registrations
GMP Accreditation and Audits
Gap Analysis
License Variations
eCTD Publishing
Pharmacovigilance xEVMPD/QPPV

Commercial

Technology transfer – technology appraisal, intellectual property protection
Grant support – e.g. Innovate UK BioMedical Catalyst / SMART Awards
Product design and realisation – e.g. contract manufacturing, packaging, sterilisation, distribution
Technology/competitor analysis
Market research reports – market opportunity, pricing, competitor intensity

Regulatory/Quality

Consultancy e.g. orientation around medical device regulation
Competent Authority (CA) and regulatory agency advice meetings
Early-stage assessment to determine medical device risk classification
New Production Development - advice for CE marking (EU) and UKCA marking (UK)
MDD to EU MDR 2017/745 Gap analysis
Advice and submissions for FDA registration – 510(k/PMA/de novo (USA)
Software as a Medical Device (Sa)MD) / Medical Device Software (MDSW)
Technical File – advice, templates, construction
Development of the ER / GSPRs checklists
Quality Management Systems - ISO 13485 certification/ ISO 14971, and other applicable standards
Clinical Evaluation Reports (CER) and lifecycle planning (PMS, PMCF etc)
MHRA registration

Commercial

Technology transfer – technology appraisal, intellectual property protection
Grant support – e.g. Innovate UK BioMedical Catalyst / SMART Awards
Product design and realisation – e.g. contract manufacturing, packaging, sterilisation, distribution
Technology/competitor analysis
Market research reports – market opportunity, pricing, competitor intensity

Regulatory/Quality

Registration of your Food Supplements with the Food Standards Agency ( UK ) or the relevant authority in the Country of your choice.
Assistance with location of Registered Importer to assist with product launch.
Label Checks for compliance with relevant authorities.
Medical claims checks

Commercial

Technology transfer – technology appraisal, intellectual property protection
Grant support – e.g. Innovate UK BioMedical Catalyst / SMART Awards
Product design and realisation – e.g. contract manufacturing, packaging, sterilisation, distribution
Technology/competitor analysis
Market research reports – market opportunity, pricing, competitor intensity

Regulatory/Quality

Over the counter drugs ( OTC) are those available without a prescription.
Full support available for your application to register with the appropriate authority.
Commercial assistance available with your product launch.

Commercial

Technology transfer – technology appraisal, intellectual property protection
Grant support – e.g. Innovate UK BioMedical Catalyst / SMART Awards
Product design and realisation – e.g. contract manufacturing, packaging, sterilisation, distribution
Technology/competitor analysis
Market research reports – market opportunity, pricing, competitor intensity