20+ years of experience
Expertise
Our specialist team of senior-level pharmaceutical industry experts has a proven track record of successfully supporting companies worldwide throughout their medicinal product and medical device development lifecycle.
Our team of pharmaceutical consultants understands the requirements of each phase and aspect of medicinal/device development and regulatory approval across therapeutic areas and product/device types.
We consult on non-clinical, clinical, strategic development, and product safety issues.
We have over two decades of proven success in providing effective solutions to the global pharmaceutical, biotechnology, and medical device sectors.
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Medicinal products
Our specialist team of pharmaceutical consultants offer scientific expertise, specialised knowledge, and experience across all phases of medicinal product development and the intricacies of regulatory compliance (EMA, MHRA, FDA) from non-clinical to regulatory approval.
Examples:
General Sales List, pharmacy only, prescription only, controlled drugs.
Biologics and Biosimilars
Do you need timely, accurate, and up-to-date advice regarding the diverse and sometimes confusing license applications and regulatory approval processes?
Our experts can help you avoid unnecessary launch delays and ensure you meet regulatory requirements.
Examples:
Biological products, including vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Any biosimilar or interchangeable biosimilar medicine.
Advanced Therapy Medicinal Products
Advanced therapy medicinal products (ATMPs) face several challenges during development, approval and postmarketing, including uncertainty about the product's benefit-risk balance, limitations of nonclinical development, and complex quality aspects of highly individualised advanced therapies.
We have in-depth knowledge and expertise in the regulatory approval processes for innovative therapies that mainly target orphan diseases and high unmet medical needs.
Examples:
Gene therapies, somatic-cell therapy medicine, tissue-engineered medicines, combined ATMPs.
Medical Devices
Our experts can help you avoid unnecessary launch delays and ensure you meet regulatory requirements.
Examples:
Single-use devices, implantable devices, in vitro diagnostics, and combination products.
