Preclinical / Nonclinical
Preclinical (nonclinical) development refers to the process through which investigational drugs are subjected to extensive laboratory testing to determine their safety for humans.
Biopharmaceuticals
Manufacturing
Introduction
Compliant biopharmaceutical manufacturing made easy
The processes and equipment used to manufacture biological products can be particularly complicated — even more than for pharmaceutical products. We help our clients design manufacturing processes that ensure product yield, purity and bioactivity, and process scalability, while ensuring compliance to all elements of regulatory and quality requirements.
Our experience means that we remain commercially focused while delivering to the highest regulatory and quality standards expected of biopharmaceuticals manufacturers.
Underpinned by extensive, practical experience within the biologics, biopharmaceuticals and vaccines industries, our professional quality and regulatory consultants are available to support you from process development, optimisation, and validation right through to inspection, approval, and beyond.
This includes “man in the plant” services for our clients that use the services of contract manufacturers.
Process development
and validation
As manufacturing process are developed and process optimisation starts, we will help you develop your biologics Validation Master Plan (VMP); summarising the validation activities that regulators will expect to see as part of their review and pre-approval activities.
Our consultants will help draft all aspects of the VMP including process, cleaning, equipment, analytical, and facilities and utilities validation. Additionally, we’ll also provide a “man in the plant” service to ensure that all validation and manufacturing activities are followed as intended and approved.
Discover more about validation services via our resource centre.
Facilities, utilities,
and equipment
The facilities, utilities, and equipment used to manufacture, purify and formulate biopharmaceuticals can directly influence their safety, quality, and efficacy. We support our clients in specifying all aspects of the manufacturing activities including facilities, utilities and equipment to ensure compliance and control recognised quality standards including ensuring URS, IQ, OQ and PQ are documented — further assuring the manufacture of consistently compliant medicines.
Analytical development
Biopharmaceutical products require detailed analysis as part of the licence submission package to assure quality, safety and efficacy. Woodley BioReg have developed and successfully used a knowledge-based analytical development processes that enables a tailored range of bio-analytical methods. Our approach allows the rapid identification of appropriate and applicable analytical techniques, as well as defining tests for characterisation, release and product quality specification. Through this, we eliminate inappropriate or redundant methods.
We offer a wide range of support in all aspects of analytical development, including product characterisation strategies, preparation of SOPs and validation documentation, preparation and submission of comparability protocols and the development of licence application submission components in eCTD format.
Discover more about analytical development via our resource centre.
CMC
Once developed, optimised, validated and used operationally, the manufacturing processes, bioanalytical test, and results form a critical part for the approval of biological medicines. Given our expertise in the development of biopharmaceuticals, Woodley BioReg is extensively involved in the preparation of all aspects of the Chemistry, Manufacturing and Controls (CMC) parts of the licence applications.
Our practical hands-on experience with a wide range of processes and experience of regulatory requirements places us in a unique position to provide unmatched levels and support to our clients. Few other regulatory consultancies can match our level of practical knowledge and expertise in the development of biopharmaceutical, biosimilars and vaccines.
GMP/cGMP
GMP compliance is a legal requirement for all manufacturers of medicinal products and without it, products will not be approved. We’re able to support our clients through the entire process of GMP systems development, implementation and certification because, unusually for a regulatory consultancy, Woodley BioReg holds a GMP licence (MIA and WDA) from the UK’s MHRA – evidencing our unique ability to be able to advise and guide you through the GMP process.
Our quality consultants live and breathe GMP, and will help you secure accreditation from your selected competent authority.
Discover more about GMP/cGMP via our resource centre
Audits
Whether it’s a regulatory agency audit before your Marketing Authorisation is granted, or a self-audit to ensure compliance, or even a “for cause” audit, we will help to prepare for, carry out, and assess the audit outcomes to ensure the appropriate remediation activities. All of our auditors have industry experience including Responsible Person (RP) status, biologics Qualified Person (QP) status and ex-agency (MHRA, FDA, BfArM) personnel.
Find out more about audits, via our resource centre.
Quality Management Systems (QMS)
As part of our GMP compliance services and activities, we can provide expert guidance and support for quality systems from the development and implementation of new systems, to the evaluation and remediation of existing ones. Our consultants utilise their knowledge and experience to ensure the most appropriate recommendations are made to ensure continued compliance.
To read more about QMS, visit our resource centre.
