The development process for medicinal products and medical devices is complex and highly regulated, and the pharmaceutical industry is evolving faster than ever. So, staying compliant with regulations is becoming ever more challenging. To do this successfully, it’s vital that businesses of all sizes invest in strategic regulatory affairs to develop a comprehensive approach to regulatory compliance and manage risk.
MWB Consulting can help you successfully navigate this landscape – from clinical trial regulation to pharmacovigilance and medical device vigilance. By drawing on 20 years of experience, MWB Consulting is uniquely placed to take a global view, build strong working relationships with regulatory teams and partner with your organisation in a way that works for you. All of which can help you optimise efficiency, save time, control costs, manage timelines, and maximise the probability of successful entry into the market.
Why regulatory affairs poses such a challenge
Regulatory compliance is a demanding and resource-intensive aspect of drug development due to its intricacy and the importance of maintaining patient safety. The scope is broad, encompassing industry guidelines, clinical trial regulations, regulatory requirements for product approval and market access, and pharmacovigilance or medical device vigilance. To add further complexity, global regulatory authorities have different country-specific requirements and constant scientific advancement makes keeping up with the latest regulations a challenge.
If you work in a small or medium-sized enterprise (SME), you may have limited access to in-house regulatory experts. Navigating the complexities of regulatory requirements without specialist knowledge and experience can tie up your team and increase the time it takes to bring your products to market. What’s more, mistakes can be costly, resulting in rejections, fines, a damaged reputation, and even legal action.
Why MWB Consulting can help you overcome these regulatory challenges
20 years of experience
The regulatory landscape is demanding, and businesses need in-depth knowledge and meticulous attention to detail to ensure their medicinal products or medical devices meet regulatory requirements throughout their life cycles.
If you don’t have an in-house team to cover this ongoing work, utilising strategic regulatory affairs consulting services like those provided by MWB Consulting allows you to tap into highly experienced industry experts and a network of senior specialists without increasing your permanent headcount.
We have 20 years of regulatory experience, so we fully understand the requirements of each phase and aspect of medicinal or device development and regulatory approval across different therapeutic areas or product/device types. So, we can support you through every step of the development journey – toward product launch and beyond.
Global reach
Planning for and addressing multiple regional regulatory requirements simultaneously is the most efficient way to get products to market quickly.
At MWB Consulting, we take a global view and have extensive experience working with regulatory bodies around the world. This includes:
- Interpreting EU, UK and US agency requirements and trends and designing regulatory strategies to meet these.
- Holding SME designation – Providing an EU/UK representative office for EMA/EU National Competent Authorities (NCAs)/MHRA liaison.
- Subject matter experts for FDA meetings.
- Advising on and managing application and maintenance of accelerated programmes with EMA, MHRA and FDA, including PRIMEEMA and NCA liaison (e.g. EMA Scientific Advice, National Scientific Advice, Paediatric Scientific Advice).
Looking for support for your clinical development project? Or need to troubleshoot regulatory or clinical trial issues?
Contact us today for an initial, free-of-charge discussion with a senior consultant about your project.
Let’s TalkCase Study:
A US development company wanted to submit for Orphan Designation for an innovative immunological therapy and needed to prepare a submission to EMA COMP.
With only a handful of paediatric subjects worldwide and challenges estimating prevalence across a number of organs where the disease might manifest, a novel triangulation method was designed to estimate prevalence which involved transposition of Japanese data to the European setting, prevalence of analog diseases using a physician survey, and a ‘sum of organ manifestations’.
COMP accepted the method, Orphan Designation was obtained and the product was acquired by a global pharmaceutical company at the end of Phase 2a.
Collaborative partnerships
Developing effective relationships with regulatory agencies takes time and may be challenging for companies new to the market.
However, we can bridge the gap between pharma or biotechnology businesses and regulatory agencies. We’ve spent years developing strong working partnerships with the European Medicines Agency (EMA), Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, Food and Drug Administration (FDA) in the US and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
We can help you navigate the entire relationship with regulatory agencies. This could include all meetings (including pre-IND, Innovation Task Force (ITF) meetings, scientific advice meetings and pre-submission meetings), promptly responding to queries, defending challenging submissions (for example, Paediatric Investigation Plans (PIP), and planning for Health Technology Assessment (HTA) meetings in advance so that the required evidence can be collected before market access.
A flexible approach
Regulatory affairs is always evolving, so we tailor our approach to your drug or medical device and your individual needs and circumstances. Our team of experienced regulatory affairs professionals are skilled at both keeping abreast of wide-ranging trends that impact the entire regulatory landscape and preparing technical dossiers and documentation that require meticulous attention to detail.
We’re available to troubleshoot single issues or ad-hoc projects. Our cross-functional team provides effective and rapid problem-solving when you need it. Alternatively, we can take a strategic approach to end-to-end planning and tactics, forming specialised teams to partner with you throughout a single regulatory life cycle or over a number of years.
Either way, we aim to help you improve time to market, control costs, hit deadlines, and maximise your success.
Case Study:
A subsidiary of a global pharmaceutical company needed advice in respect of Article 20 and Article 31 procedures commenced by the EMA’s CHMP for two of their products.
We assisted with regulatory interactions and proposed risk minimisation measures. We developed a key message communication strategy, responded to CHMP, attended an oral examination as safety experts and helped negotiate follow-up.
This resulted in a new risk management plan and successful retention of products on the market.
Rather than you struggling with the intricacies of the regulation of medicinal products and medical devices, let us ease the process to help you save time, money and effort and set your product off on the best footing.
Looking for support for your clinical development project? Or need to troubleshoot regulatory or clinical trial issues?
Contact us today for an initial, free-of-charge discussion with a senior consultant about your project.
Let’s Talk