Drug or Device Development

InViva can support drug discovery and development process throughout the development journey including:  

• 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 

- Analytical Development

Pharmaceutical and healthcare products require detailed analysis — chemically, biochemically, and preclinical assessments — as part of the license submission package to assure quality, safety, and efficacy.

InViva’s knowledge-based analytical development process uses a wide-range of techniques to gain information about a target molecule’s properties and to eliminate inappropriate or redundant methods.

The methods selected probe the known structure and properties of the product, e.g. stereochemistry, protein, lipid, carbohydrate, primary, secondary, tertiary, and if relevant quaternary structure, PTMs, etc.

Analytical Testing

Analytical testing is used in all aspects of drug and device development including raw material testing, in-process testing, release testing, stability testing, investigative testing, and post registration testing for drug substances and products. It forms an important part of the analytical development strategy for several reasons including: 

• Analytical tests can be simple and cheap to perform 

• Analytical methods are well understood and relatively easy to validate 

• Analytical tests are relatively easy to specify and can be used throughout manufacture, release, and shelf life 

• Analytical tests can be used to measure several parameters of a range of constituent components 

Types of tests are: 

Each test method — analytical or biochemical — must be appropriately validated against ICH requirements, under which methods are classed as assay, identity, or impurity tests. Each method requires a documented assessment on its accuracy, precision, repeatability, specificity, detection limit, quantitation limit, linearity, range defined in validation activities, validation protocols and reported in validation reports.

Regulatory agencies espouse the importance of a robust and well-documented analytical development strategy by their acceptance of biochemical bridging for post-marketing activities, such as comparability protocols and/or equivalence protocols in support of process changes and technology transfer activities.

The evolution and derivation of the selected test methods (and the omission of other methods) must be documented as part of the licence submission package both at clinical trials/IND application and at MAA stages. A detailed justification of the test specifications must be provided as part of any submission package justifying the inclusion and exclusion criteria for tests.

 

How InViva can help with analytical development

We offers a wide range of analytical development support activities including:

• Development of analytical development and product characterisation strategies

• Development and preparation of SOPs and validation documentation,

• Preparation and submission of comparability protocols

• Preparation of license application submission components in eCTD format

InViva’s approach is knowledge-based and ensures regulatory acceptance through robust and detailed justification that is underpinned by data. Our approach has been widely applied and accepted for pharmaceutical and biological products.

Pharmaceutical companies typically manufacture at laboratory bench and pilot-scale for preliminary preclinical and toxicology studies and on occasion for phase I clinical trials. As more product is required to support phase II and phase III clinical studies, the manufacturing operations need to be scaled-up and prepared for process validation.

A key part of the process development activities is the early identification of critical process steps to significantly help the design and delivery of process validation. Inadequate or poorly defined process development and identification of critical process steps can seriously impact the long-term product viability when product lifecycle changes can be commercially inhibitory.

Process development and validation should be documented in a systematic fashion to accurately document the changes made to the process. Documents needed to track the process include:

• Process development reports

• Technical reports

• Validation master plan

• Validation protocols including IQ, OQ, and PQ

How InViva can help with process development

InViva provides assistance during all stages of process development, scale-up, validation and technology transfer. We do this by critically reviewing technical development data and reports and by ensuring that the appropriate controls are in place to enable rapid and robust validation.

InViva experts also ensure a clearly defined product development plan is in place. Working with clients to develop process development and validation plans helps deliver quality products in line with client corporate goals.

Method scouting is the term used to describe the assessment of potential test methods during the early stages of product development, when there is limited knowledge of the types of analytical procedures that may be applicable or appropriate to the product.

Method scouting involves a series of “rough and ready” experiments that are designed to determine whether a method is applicable to a test article. Scouting experiments can form part of the method development phase, and are always performed prior to method optimisation and validation. This is due to the data obtained playing an important part in the development of subsequent validation ranges and criteria.

This may be depicted as follows:

 

Method scouting and pharmaceutical development

Method scouting is a highly technical area and requires specialist analytical knowledge as well as product knowledge, expertise of analytical procedures and the target molecules. It is used in subsequent pharmaceutical development steps including:

• Manufacturing process development and refinement

• Formulation development

• Stability evaluation

• Establishing specifications

• Establishing Quality Control (QC) test methods and product quality specifications (PQS)

Robust and well-documented method scouting is vital during preparation of the pharmaceutical development sections of the dossier.

How InViva can help with method scouting

InViva are experts in a wide range of analytical methods and product types to help and advise clients on procedures and techniques available throughout the development and registration stages of a product.

InViva provides expert guidance and consultation gained through practical and successful industry experience in order to develop methods that can be validated and documented in eCTD.

Successful project management of biopharmaceutical,  pharmaceutical, healthcare, over-the-counter (OTC), and medical device products requires a unique blend of technical, scientific, regulatory, and quality skills to ensure focus and delivery of those critical activities that will directly impact the product registration and approval.

Often the commercial success of a project depends on the effective management throughout the clinical, product development, commercialisation, and licensing stages. Many companies find they lack the blend of skills within their own resource pool to manage this complex blend of activities.

How InViva can help

InViva has extensive scientific, healthcare, and pharmaceutical sector expertise and can provide leadership to a project team. We have supported biopharmaceutical projects through early pre-clinical development, clinical development, process development and validation, and product licensure. Our remit includes agency interactions, meetings for scientific advice, and IND submissions.

InViva has also managed the regulatory and submission process by providing the interface between all stakeholders and departments — including third party manufacturers — and regulatory agencies.

InViva has overseen contract manufacturers through a “man in the plant” model to ensure that the contract manufacturer’s activities are planned, executed and documented, in accordance with the client’s objectives and in compliance with cGMP.

InViva’s project managers are highly skilled and experienced, with in-depth understanding of all aspects of the entire drug development process. We significantly enhance our client’s projects by providing support, including:

• Primary point of contact and effective flow of information

• Early identification of project risks

• Contingency and scenario planning

• Rapid resolution of issues

• Scope change management

• Resource management

• Maintenance of a highly effective project team who are flexible and responsive

• Ensuring the project team are focused on a common set of objectives

• Ensuring project objectives & deliverables are met on time & in full

• Provision of meaningful project metrics

The long and costly development process for the development of new pharmaceuticals places huge commercial pressures on companies to secure Marketing Authorisations in the shortest time.

Regulatory agency meetings play an important part in responding to agency concerns and developing a consensus for the development and registration process. Effective agency interactions, communication, and management are critical to the timely success of product approval.

Regulatory agencies permit and encourage early engagement between technical and scientific companies, assessors, and reviewers to ensure any formal submissions for either clinical trials or product licensure are reviewed and approved expeditiously. This involves discussion and negotiations, to ensure regulations are interpreted and applied in line with expectations.

Three regulatory agencies for the larger markets and major regions are:

FAD, EMD, PMDA and MHRA

 

How InViva can help

InViva provides a full range of services to support pharmaceuticals, biopharmaceuticals, healthcare, OTC products, and medical devices from the development of registration strategies to the preparation and submission of registrations documents in eCTD format.

InViva prepares and support clients through a range of services including:

• Discussing the options for registration

• Arranging agency meetings and providing briefing documents in line with regulatory requirements

• Assisting in the preparation of meeting presentations, including key decisions

• Participating in regulatory agency meetings and supporting client positions through sound and scientific argument

• Ensuring compliance to the relevant regulations

• Ensuring post-meeting notes are accurate and complete and that any actions are assigned

• Following up with regulatory agencies to ensure any actions are completed

InViva’s experience in managing and navigating meetings with regulatory bodies globally is underpinned by our expert knowledge in science, regulatory affairs, and quality risk management. Our most frequent agency meetings include:

• IND meetings – pre-IND, EOP meetings

• Scientific advice meetings

• Orphan designation meetings

• Pre-submission meetings (MAA and BLA)