A broad range of services are available to support your CMC and pharmaceutical development requirements. The emphasis is on delivering quality data and services to pre-agreed timelines and objectives. At all times the client is kept informed of progress, made aware of potential and/or actual issues and advised on consequential implications.
A firm commitment is made to liaise closely with each client and this is considered paramount to your ultimate success.
The list below although not exhaustive, provides an overview of the services available. Click on the headings and find out more about how this Consultancy can help you.
API
and Drug Product Characterisation:
- Oversee drug characterisation and physicochemical testing, including solubility, stability, polymorphism and salt form screening
- Design and justify specifications to meet early and late phase clinical development needs
- Oversee the testing of API or drug product against approved specifications
Method Development and Validation:
- Develop and validate methods for the chemical, physical and microbial testing of pharmaceuticals to meet early and late phase clinical development needs
- Write and review formal ICH compliant validation protocols which include experimental design and acceptance criteria to support MAA and NDA filings
- Write and review formal validation protocols which include experimental design and acceptance criteria to support IMPD and IND filings.
- Oversee the validation of a method at the contract testing laboratory and write the validation report
- Write method SOPs
- Trouble shoot and improve poor performing methods
- Oversee the transfer of analytical methods from one laboratory to another, including the writing of the method transfer protocol and transfer report
John Hevizi Consultancy has a sound knowledge of the following techniques based on ‘hands on' experience and subsequent management responsibilities; HPLC (rp, np, iex, sec); CE; GLC; TLC; FT-IR; fluorescence / UV / Vis Spectroscopy (including DAD); AA / AE, DSC / TGA; Dissolution; Laser Diffraction Particle Sizing; SDS-PAGE and Western Blot. Other techniques include: Sterility testing; endotoxin testing; microbial bioburden; Microcalorimetry; DVS; FT-IR Microscopy; NIR; LC-MS; OR; Peptide Mapping; CD; XRPD; NMR; Ion Chromatography; ECD in HPLC and Immunoassays.
- Carry out technical audits and advise on the selection of QC testing contract laboratories
- Oversee QC release testing of API starting materials, API intermediates, API, raw materials, drug products and excipients
- Ensure all analytical work is carried out to cGMP
Stability Studies and Shelf Life Definition:
- Write formal ICH compliant stability protocols for API or drug product that include alert/alarm limits, alert/alarm actions, specifications and incorporate built in controls
- Write ‘developmental' stability protocols designed to assist a) drug candidate selection, b) formulation selection or c) primary packaging selection
- Oversee stability testing at the contract testing laboratory, writing stability updates and formal reports for both internal and regulatory consumption
- Analyse and interpret stability data, making recommendations for storage conditions, shelf-life or re-test period, including statistical analysis and extrapolation
- Advise and design specifications for drug product (small molecules and biopharmaceuticals) and API (including starting materials and intermediates) for “first into man” studies all the way through to Product Licence Application.
Preformulation and Formulation Development:
- Oversee the compilation of preformulation packages, which includes data such as pH/solubility profiles, pH/stability profiles, intrinsic dissolution, physical form characterisation etc.
- Manage the development and selection of first into man formulations and thereafter, formulation improvements to address the ongoing clinical program needs
CMC Project Plans (Strategic and Operational):
- Provide advice and implement pharmaceutical development strategy to meet with the clients clinical development objectives
- Work with the client to write a project plan which will include CMC activities, start dates, durations and provide a comprehensive assessment of costs, internal resource, external resource, regulatory considerations and CMC technical go / no go decision points
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Once agreed, the approved CMC project plan will be executed and managed through the selected contract organisations or using available internal resource
Project Management of Contract Organisations:
- Carry out technical audits of third party contractors
- Work with the selected contractors to manage the agreed manufacturing, preformulation, formulation, analytical and CTS work
- Represent analytical development on the clients project team and provide feedback to the team
Regulatory CMC Dossier Compilation:
- Write the CMC section for a clients regulatory submission and any subsequent amendments
- Respond to technical questions from the regulators
- Develop and implement analytical training policies, training records and training record audit programs
Analytical Development Policies:
- Develop analytical policies and procedures to meet a client's business needs and satisfy regulatory expectations (for example OSRI's; timing and extent of method validation; analytical equipment qualification; analytical training and records; control of reference standards; analytical result checking and reporting; technology transfers)
Stability Suite Management and Qualification:
- Oversee the installation and qualification of a client's stability suite installation
- Design a stability management quality procedure for the client
Analytical Reference Standards:
- Design and implement analytical reference standard procedures for reference standard establishment, storage, re-qualification and distribution
- Provide management and co-ordination of in-house analytical resources and external pharmaceutical development activities
Pharmaceutical Development Due Diligence:
- Carry out CMC due diligence on behalf of clients considering in-licence opportunities
- Assist in collating and presenting CMC data on behalf of clients preparing for out licence opportunities
