Any government or health authority approvals pertaining to any research involving human participants are considered regulatory approvals for clinical trials. If the study makes use of a product that is subject to FDA regulation, further clearances will be required.
Gain access to crucial assistance for the registration and commercialization of your whole plan
Together with a dedicated partner, reach your financial objectives and add value to your programme right away.
A manual for navigating the difficult environment of today
The journey to commercialization is arduous and iterative. In the dynamic environment of drug development, you must:
- Look for the quickest way to review your chemical.
- Navigate a challenging development process
- Minimize inefficiencies across several levels
- Ensure commercial uptake
You require a knowledgeable partner who can assist you in achieving your long-term business objective. At whatever level of your development, you can rely on us to offer an original regulatory strategy.
An ally who supports your resources
Regardless of the size of your business or the stage of product development, we can satisfy all of your regulatory needs, whether you need strategic assistance on your nonclinical strategy, registration and commercialization, or advice on your upcoming stages.
Improve your relationships, meetings, and global strategy at agencies
Biotech and pharmaceutical businesses can now obtain nearly simultaneous regulatory approval of their goods globally because of integrated global drug development. You require a knowledgeable partner who can examine your data, create your submission, and serve as your mentor at important agency meetings. We have local experts that can work closely with your team and, if necessary, even represent you at agency meetings, whether you are using the standard submission process or looking for fast-track or orphan medicine designation.
We can assist you in collaborating with the FDA, EMA, MHRA, NMPA, and PMDA to develop a regulatory solution, regardless of where you are seeking approval.
More than just regulatory assistance
A solid and early plan is the first step in maximizing the clinical and commercial value of your product. Our Market Access and Phase IV Solutions may evaluate your market environment, perform research, and share data to assist demonstrate value. We can also bolster your staff to help with message delivery and support your patients, clients, and overall access strategy.
Incorporate abilities for global development
Utilize our Molecule Development Group to reduce development “white space” and extend the useful life of your patent. With a core team of skilled doctors and project managers, you’ll obtain strategic continuity from early clinical development through Phase IV. They’ll pave your way through each stage of the drug development process. By bringing in our subject matter experts as necessary, you’ll improve continuity between research execution and strategy creation, allowing you to manage your portfolio with minimal overhead.
Derisk your progress
With a comprehensive picture of your programme, develop a comprehensive strategy and locate new efficiencies. We can offer complete coverage at every level and assist you in choosing the best course of action from the outset. Let us support your molecule from a variety of angles, including strategy, audit, submission, publishing, and post-licensing support. We offer extended solutions across our company to assist you successfully manage regulatory clearances, whether you require an addition to your team to offer advise or someone to represent your product at meetings.