MDL brings first-hand regulatory authority knowledge of drug regulation to the benefit of clients. Current knowledge of regulatory developments, both in the EU and other key markets, is supplemented by personal familiarity with the regulatory environment, its agencies and staff - how they think, act and reason. This enables MDL to offer credible regulatory reviews of development data, to perform effective gap analysis, to predict the likelihood of regulatory success and to offer strategies for dealing with regulatory authority responses.
MDL offers state-of-the-art, high-quality, reflective but responsive consultancy on all stages of clinical drug development and licensing to help clients achieve effective drug development leading to business success. By forging close relationships with clients, MDL aims to offers flexibility of response to continuing consultation through the product development cycle. MDL supports client aims and needs in a flexible, friendly and open style and has a reputation for meeting agreed deliverables on time and to client satisfaction.
MDL provides clients with the knowledge of what to do to succeed in drug development and licensing (client requirements for practical support of regulatory applications can be directed to a series of appropriate consultancies). MDL aims to help clients move from relatively-efficient drug development (doing the thing right) to effective drug development (doing the right thing). MDL gives you what to do and when to do it.
Success in pharmaceutical licensing relies on demonstrating the strengths of a product while defining its weaknesses. Too few companies recognize the strategic benefits of doing both well (and some fail to admit to the latter).
MDL encourages optimal clinical development and regulatory planning, compliant with relevant guidelines, in order to help achieve licensing targets and so reduce both cost and time to market.
Whether your business plan is to identify internal drug candidates, to acquire external new active substances (NASs) or generic products for full development or staged development, to achieve out-licensing or cooperative targets, MDL offers independent advice on what to do and what can be achieved. Whatever type of drug, or stage of its development, MDL can make a difference to your development goals. Our aim will always be to treat your business as a partnership, not as source of a one-off job.