The drug or medical device development process is complex and can be challenging for any organisation. However, this journey becomes more manageable with pharmaceutical development and regulatory consultants’ strategic guidance and regulatory expertise. These experts can guide you from the preclinical stage through clinical trials, approval, and product launch.
Launching a drug (small molecule or biologic) or medical device is a high-stakes endeavour in terms of time and money. The costs, which can range from hundreds of thousands to billions, are just the tip of the iceberg. The real risk is that about 90% of drugs fail to make it through the discovery, development, and regulatory approval process. Of these failures, 10% are attributed to a lack of commercial interest, poor strategic planning and regulatory submission.
This stark reality underscores the need for expert guidance and the potential consequences of not seeking it. With so much at stake, the ability to navigate complex global requirements, trends and emerging issues is critical to your success. Thus, it’s no wonder that more and more companies are turning to specialist pharmaceutical consultancies for support.
What are the benefits of working with a pharmaceutical consultancy?
A pharmaceutical development consultancy can help you:
- Reduce risk
- Reduce costs
- Reduce time to market
- Navigate complex regulatory landscape
- Optimise development strategies
- Maximise the likelihood of a successful drug/device launch
How do they do this?
Medicinal product and medical device development consultants offer:
- Industry-specific scientific knowledge and expertise in market dynamics and industry trends. Pharmaceutical consultancies can help you to identify and mitigate potential risks early. This proactive approach can protect your business from financial loss and damage to your reputation, giving you a sense of control over your business’s future.
- Advanced critical thinking, unique strategic insights and recommendations. End-to-end strategic planning and tactics to improve time to market, control costs, plan timelines, and maximise the probability of successful regulatory approval.
- Extensive regulatory knowledge and know-how, working with you to navigate the regulatory requirements for cross-border clinical trials, prepare for regulatory submissions, and present your medicinal product or device to regulatory agencies to maximise the probability of successful regulatory approval and avoid regulatory penalties and costly delays.
- Pharmacovigilance and medical device vigilance systems and expertise that help you build a regulatory-compliant function.
- Objective, efficient and compliant advice, helping you solve specific project issues quickly and safely, making better decisions for your business.
Consulting can be valuable for any pharmaceutical, biopharmaceutical, or MedTech company, regardless of size or stage of operation. Small- or medium-sized enterprises may not have the in-house capabilities to efficiently and safely handle every aspect of drug/device development; larger organisations may need specialist help to troubleshoot an issue they’ve not encountered before. Either way, by leveraging the expertise of experienced consultants, companies can gain a competitive edge and bring their medicinal products, biologics, medical devices, and advanced therapies (ATMPs) to market efficiently and safely.
How can MWB Consulting help you?
Are you a pharmaceutical company aiming to launch your first medicinal product in the EU, UK, or US market, and are you looking to take advantage of early access and accelerated pathways?
Are you a pharmaceutical company aiming to launch your first medicinal product in the EU, UK, or US market, and are you looking to take advantage of early access and accelerated pathways?
Are you a MedTech business looking for support in building a medical device vigilance programme grounded in quality, compliance and efficiency?
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.
Talk to us about your medicinal product/medical device development needs. We’re here to support you.
LET’S TALKHow to choose the right Pharmaceutical Development Consultancy
When choosing a drug/device development consultancy, first consider your needs. Do you need help with a scientific or regulatory project, or do you need to troubleshoot a specific problem? Are you looking for a specialist team to help you achieve your objectives?
Next, check that the consultancy can meet your needs. Do they have:
- Industry-specific knowledge and experience? Choose a consultancy where you have direct access to senior consultants throughout your project.
- Specialists that can consult on your stage(s) of medicinal product/device development and provide regulatory knowledge and expertise in the country you are conducting clinical trials or seeking regulatory approval? Choose a team of consultants who work together to achieve the best outcome for your business.
- An excellent reputation within the industry, a proven track record? Choose consultants who can give examples and speak directly about successes in the area where you need help.
- Data management, security and compliance systems to keep your data safe? Choose a consultancy whose working practices are underpinned by quality, compliance, efficiency and security.
- Robust communication frameworks and the ability to work across time zones? Choose a consultancy that matches your communication style and approach to collaboration. Working with consultants should feel like a partnership rather than a contracted service.
In an industry that constantly evolves, technology and market trends change in the blink of an eye, and keeping abreast of regulatory requirements poses substantial challenges; partnering with a pharmaceutical consultancy can help you foster a culture of strategic planning, embrace technological advancements, and transform challenges into drivers for future success.