Featured Services

GMP & Quality System Services
Validation Services
Computer Systems Validation
Regulatory Affairs & Compliance Services
Due Diligence

We Offer

compliance services
We provide professional services, consultation and training in the following Pharmaceutical and Biotech Quality areas:
GMP Audits; Quality Systems; Manufacturing; Lab and Analytical Methods; Remediations- 483s and Health Canada Observations
Gap Analysis and Remediation; Deviations and Incidents; Failure Investigation; CAPAs; Complaint Handling and Recall
CMC Change Management; Batch Production Records; QA Release; SOPs and Documentation; ISO 13485 and ISO 9001; Risk Assessment
Inspection Readiness; Validation
Water System Validation; Equipment Validation; Facility Validation; Utilities Validation; Analytical Method Validation
We prepare strategy include: Audit; Development of Validation Master Plan (VMP); IQ, OQ and PQ Execution; Protocol and Reporting; Development of internal auditing system with respect to Validation services.
process validation
CSV Audit - A Subject-based readiness analysis
CSV Strategy - strategy tailored to your processes, organisation and IT and automation landscape with equal focus on cost factor. This risk based approach will help you to carry out validation projects faster and with significantly lower outlay.
CSV Implementation - Our consultants will support your validation projects in a variety of roles e.g. Project MAnager, Validation engineer, Complaince Auditor.
process validation
We provide professional services, consultation & training in the following sectors: Drug Products; Biologics; Medical Devices; Natural Health Products Veterinary Products; Nutraceuticals; OTCs; Cosmetics; Food Products Disinfectants; Pesticides; Consumer and Personal Care; API(Bulk Pharmaceuticals)
process validation
GAP Analysis and REmediation; Remediations - 483s; Health Canada/FDA Observations; Deviations and Incidents; Failure Investigations; CAPAs

Computer System Validation Includes:

We audit using a standardized method, taking international requirements into account. You decide which area we should audit. For example, an audit for preparing an official inspection can therefore be carried out, (e.g. FDA) or a subject-based readiness analysis, e.g. 21CFR 11.

A good CSV strategy is tailored to your processes, your organisation and IT and automation landscape. We start by identifying the current situation with the help of a standardised method, e.g. reality check (link) and will identify the organisational and technical measures particular to your requirements. In consultation with your experts we will develop a validation strategy that will satisfy the requirements of the authorities and your customers for the long term. Equally, the focus is on: the cost factor. The aims of the strategy are not only to meet requirements but equally to implement the validation tasks economically. The risk-based approach will help you to carry out future validation projects faster and with a significantly lower outlay. As an additional benefit for suppliers of machines and equipment, you are able to offer a standardised validation package that is considerably below previous costs. This service is required more and more frequently when purchasing machines and will therefore significantly increase your market opportunities.

Our consultants will support your validation projects in a variety of roles, e.g. as a project manager or as a validation engineer. The experience of our CSV consultants in validating computerised systems goes back several decades and encompasses all IT, laboratory and automation systems. We know the dangers and sources of error during implementation only too well. Benefit from our expertise and avoid the mistakes made by others in the past.