Regulatory Affairs

We have a wealth of experience in the preparation and submission of both manufacturing licenses such as Investigational New Drugs (IND), New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Drug Master Files (DMF) and Biologics License Applications (BLA).

Our consultants are experts in assisting our Medical Device clientele with their MDR/IVDR transitions, handling the complexity of the project and associated documentation.

Mock Inspections

Give your site, staff and management teams an advantage in an upcoming inspection. 

Our mock audits are based on in-depth experience of the various approaches taken by regulatory bodies. 

We provide reports in the same format as you would receive from a registered authority and are on hand to assist you in addressing any observations prior to the readiness of the regulatory agency.

Inspection Readiness

Ensuring that your site, staff and management teams are prepared to handle inspection is crucial. We offer a wide range of training, from inspection management to backroom logistics. This ensures your employees can feel confident to respond to any inspections with the diligence required to pass.

In-house Training

With the strong belief that training should not be standard across the board, our consultants have developed bespoke techniques and programs to guarantee all training is carried out to effectively suit your needs. We cover cGMP, cGDP, Pre-Inspection/Inspection Handling, Analytical Laboratory GMP, Root Cause Analysis, Deviation Investigation, Out of Specification Handling, Auditor Training and Data Integrity Auditor Training.

Compliance Manufacturing

A well developed planned maintenance program is essential to assuring the reliability of your plant. Moreover it ensures ongoing regulatory and legal compliance. We take a logical, systematic approach to identify your operationally critical equipment and build systems and processes to ensure both compliance and reliability. Ultimately ensuring you maintain excellent customer service at optimal cost.

– Implementation of Computerised Maintenance management systems (CMMS)
– Development of Planned Maintenance Programs
– Establishment of Maintenance KPIs and SLAs

Compliance Process

Ensuring your systems, procedures and documentation are compliant is vital in the life science sector, but sometimes elements can be overlooked. We offer a wide range of technical support to analyse procedures and processes and verify the solution implemented is clean and fit for your purpose.

We can work with you to develop systems and processes to ensure compliance with:

– Pressure System Safety Regulations
– Lifting Operations and Lifting equipment Regulations
– Dangerous Substances and Explosive Atmospheres Regulations
– F-Gas regulations
– GMP
– ISO 45001 Safety Management System
– ISO 9001 Quality Management System
– ISO 14001 Environmental Management System

Operational & Process Efficiencies

Having all your systems and procedures efficiently aligned seems like such a simple statement, however, this is an area where we regularly see conflicting client procedures resulting in operational and process flaws. By allowing us the ability to review and advise on these procedures, we can optimise your operations and align processes for a more productive route to delivery.

Operational Excellence

Operational Excellence is a frequently used term but is rarely held through as accountable to the completion of a project. Our consultants have years of experience in providing robust, detailed strategies outlining the elemental requirements required for the delivery of a product to market.

Quality by Design

The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasises product and process understanding, process control, and is based on sound science and quality risk management. Quality by Design (QbD) is emerging to enhance the assurance of safe, effective drug supply to the consumer and also promises to significantly improve manufacturing quality performance.

Project Engineering

Our consultants can support projects across the entire project cycle. This could range from the engineering procurement and construction management (EPCM) to the design of process, or packaging systems.