Demands for resources within the pharmaceutical industry are at an all time high. For over 10 years, Generic has supported and supplied many UK and pan-European pharmaceutical companies with consultancy experience. Generic has assembled specialist teams to deliver time and cost-critical resources.

The pharmaceutical industry is one of most stringently regulated in the world. Numerous regulatory bodies require that research and development, production, storage, distribution, marketing and the sale of drugs are carried out to the highest possible standards. Generic helps clients to meet those standards. Generic's portfolio of consultants provides expertise and guidance as well as interim management, auditing and project-based consultancy services. Experience includes:

Quality Assurance and Quality Control

QA/QC systems, management, standard operating procedures for compliance with GMP/cGMP/GLP.

Regulatory Affairs

European and global regulatory framework submissions, licence applications and maintenance.

Qualified Person

Primary and secondary batch release, parallel import compliance, IMP release in compliance to the clinical trial directive.

GMP/cGMP Auditing

Holistic approach to the assessment of manufacturing processes, report writing, supplier site auditing, in-house GMP/cGMP auditing, mock egulatory inspections, guidance and advice within API manufacture.

GMP/cGMP Training

On site GMP training for existing staff.

GCP/GLP Auditing

Auditing of clinical and laboratory practices within a clinical drug development arena, supplier site investigation, on-site auditing.

ISO Regulatory Standards

Expertise in ISO standards, mock audits, ISO accredited lead auditors.

Pharmacovigilance

Adverse reaction reporting, signal detection, PSURs and EEA QP (for Pharmacovigilance).

Validation

Computer systems, process, production, utilities, laboratory and control systems.

Auditing and Training

GMP/cGMP/GLP internal and external.

Biostatistics

Statistical support into clinical trials, SAS programming, expert consultancy.

Clinical Staff

Clinical research manager, clinical research associates, higher scientists, assay development scientists.