Phase2Phase offers senior level expertise within all biotech and pharmaceutical development phases, including CMC (Chemistry, Manufacturing and Controls), QA (Quality Assurance), RA (Regulatory Affairs), Supply Chain/Transportation/Trade Compliance. Many of our clients are established Biopharma companies, but we also offer tailored solutions for small startups to facilitate the path from drug discovery to clinical development
With a strong drive for entrepreneurship we are committed to accelerating the development of Biopharma innovations.
Senior CMC Expertise
CMC is a crucial part of all stages of drug development – from drug discovery through clinical development to market approval and beyond.
With long experience and an agile mindset we provide companies with tailored solutions to secure a solid CMC strategy in each phase of the drug development life cycle. Our services cover a wide range of areas including expert advice on CMC strategies, contract negotiations and CMC project management, and we set a pride in helping our clients deliver cost effective drug development within set timelines by mitigating risks and prepare customers to meet future regulatory demands.
We help you manage and ensure the correct level of quality and integrity at every stage of your drug development project. Examples of assignments: QMS, Audits, Interim Head of Quality, Vendor Qualification, etc.
We help you navigate the regulatory requirements for biologicals. We offer advice on regulatory strategies, IND/IMPD authoring, gap analyses, due diligence.
Supply Chain/Transportation/Trade Compliance
Transporting pharmaceuticals, biologics and/or samples require skills in transportation, customs, regulatory and sanctions compliance. We can support in all of these areas.
Strengthening Biopharma development
With a strong entrepreneurial drive, we are committed to strengthening life science development. Through our expertise, we are a trusted partner to provide expert advice and due diligence assessments of projects and companies in contract negotiations and prior to project acquisitions or investments. In validated investment cases we are open to share risks in terms of funding. Our investments are made separately or as a part of an investor network.
If you are interested in discussions regarding future investments, we encourage you to contact us.