Consultancy Services for Pharmaceutical, Biotechnology, and Life Sciences Industries
Established in 1991, our esteemed consultancy specializes in providing strategic solutions to pharmaceutical, biotechnology, and life sciences organizations. With a proven track record of empowering more than 350 global clients, we remain committed to fostering innovation and progress within these vital industries.
Scientific Affairs
Our team is highly experienced in evaluation and advice on medicinal chemistry and pharmaceutics, pre-clinical and clinical data, registration data to FDA, EU, TGA, IP, pre-clinical data dossiers for Phase I studies and more. We can also provide project management of drug discovery & development programs to IND-ready.
Technical Services
We offer gap analysis, pre-inspection and compliance audits with global best practices in pharmaceutical “GXP” to US-FDA, EU, TGA, PIC/S, APVMA requirements, technical due diligence, evaluation and risk analysis of product/technology acquisition, facility design to regulatory compliance, medicines manufacture (including biosimilars), process development and validation and technology transfer and commercialisation.
Intellectual Property & Legal
Our experienced team can provide commercialisation of novel pharmaceutical compounds and products, expert witness in international and domestic legal litigation matters pertaining to regulatory, pharmaceutics, patent issues, product and intellectual property evaluation and more.
Professional Organisations & Affiliations
Dr Philip Marshall is a Fellow and Chartered Chemist of the Royal Australian Chemical Society, a Member of the Association of Therapeutic Goods Consultants Inc and an Authorised APVMA GMP Auditor (retired).
About
Dr Philip Marshall, founder and director of Pharmchem Technical Services Pty Ltd, is an acknowledged international expert in the pharmaceutical sciences and medicinal chemistry. He has over 40 years of experience in the pharmaceutical and related life sciences industry, having held senior executive positions with major pharmaceutical companies in scientific affairs, quality assurance, compliance, research and development, drug discovery, manufacturing, clinical research and IP management. He has also served as an independent Expert Witness in many Australian and international court matters in IP litigation. His high level knowledge and experience in compliance auditing to codes of Good Manufacturing Practices (GMP), Good Laboratory (Control) Practices (GLP), Good Clinical (Research) Practices (GCP), pharmacovigilance (PhV) to PIC/S, Australian (TGA) and international regulatory standards (EU, FDA, WHO) makes him an invaluable asset to the team.
Our Lab
At Pharmchem Technical Services we have the capability to evaluate pre-clinical data dossiers for Phase I studies and carry out gap analysis, pre-inspection and compliance audits with global best practices in pharmaceutical “GXP” to US-FDA, EU, TGA, PIC/S, APVMA requirements. We are highly experienced in process development, validation and project management of drug discovery & development programs to IND-ready.
Certified Testing Services for NSF/ANSI Organic Compliance
At Pharmchem Technical Services, our advanced lab offers testing services aligned with NSF/ANSI Organic Certification 305/2016 guidelines. We ensure product quality and safety, protecting your brand reputation. Our services cover organic ingredient verification, manufacturing compliance, formulation evaluation, prohibited substance testing, and ongoing compliance support. Trust us for your organic certification needs, adhering to the rigorous standards demanded by regulatory authorities and consumers.