At Pharma Design, we provide regulatory affairs consulting and regulatory affairs services for biotechs and small to mid-sized pharmaceutical companies developing innovative medicines.
Our consultants offer hands-on regulatory strategy support at every stage of clinical development, helping you align European requirements with your global development plan.
We have provided advice and direct support to large and small drug developers since 2009, with particular depth in oncology, psychiatry, neurology, immunology, cardiovascular, infective and rare diseases. Our aim is to help you save time, cost and resources, and to improve your chances of regulatory success.
Why Biotechs Work With Our Regulatory Affairs Consultants
Small and mid-sized biotechs rarely have a full in-house regulatory function. Working with experienced regulatory affairs consultants gives you access to senior-level expertise at the moments it matters most.
We take an impartial and independent view of your programme, helping you focus on the activities and endpoints most likely to support regulatory approval and avoid avoidable delays.
Our Regulatory Affairs Services
Clinical Trial Applications (CTA and modifications)
We produce and submit clinical trial applications across the EU, UK and Switzerland. Our consultants are experienced users of the regulatory portals you will encounter, including CTIS (Clinical Trial Information System) for EU CTA submissions and IRAS for UK submissions.
We support clients from CTA submission through to approval, providing:
- CTA strategy and planning aligned with your clinical development plan
- CTIS submission and IRAS submission management
- Protocol review and pre-submission queries
- Validation query response and post-approval modifications
- CTA support in Switzerland and Eastern European markets
Our clinical trial consultants work within tight timelines and offer competitive pricing relative to other service providers in Western Europe.
EU and UK Marketing Authorisation Applications (MAA)
We support biotechs with marketing authorisation application preparation and submission across the EU, UK and Switzerland. Our team has successfully managed MAA submissions for over fifteen years, including centralised procedure applications to EMA.
Our MAA support includes:
- Marketing Authorisation Holder (MAH) responsibilities and representation
- MAA strategy from early clinical development through to submission
- Full MAA dossier preparation and review
- Pre-submission meetings and validation
- Variations, renewals and post-authorisation activities
EMA and MHRA Scientific Advice
We support biotechs in obtaining scientific advice from regulatory authorities before key development milestones, including before MAA submission and ahead of pivotal clinical trials.
We have extensive experience preparing and delivering scientific advice procedures with:
- Joint scientific consultation (JSC) and parallel scientific advice
- EMA scientific advice and protocol assistance
- MHRA scientific advice
- Swissmedic and national agency support
- US FDA Type B and Type C meetings
Paediatric Investigation Plans (PIP)
We specialise in the production and submission of Paediatric Investigation Plans (PIP) to European agencies, including EMA, MHRA and Swissmedic via their respective portals.
Since 2009, we have produced and submitted over 47 initial PIPs and 30 PIP modifications.
In the past year alone, we submitted 15 initial PIPs to MHRA and 5 PIP modifications for mRNA products across a range of therapeutic areas.
Our PIP support covers:
- Positioning advice where paediatric agreement is late relative to adult development or MAA filing plans
- PIP strategy development aligned with your clinical development plan
- Initial PIP authoring and submission
- PIP modifications and compliance checks
- PDCO interaction and response management
ILAP, PRIME and PIM Designation Support
We help biotechs access expedited regulatory pathways across the EU and UK, including:
- ILAP (Innovative Licensing and Access Pathway) applications in the UK
- MHRA ILAP Innovation Passport and Target Development Profile (TDP) preparation
- EMA PRIME (Priority Medicines) eligibility and submissions
- PIM (Promising Innovative Medicine) designation
- EAMS (Early Access to Medicines Scheme) support
These pathways can materially accelerate development and access timelines when used at the right stage of your programme.
Orphan Drug Designation
We also specialise in the production and submission of orphan drug designation applications to European agencies, including EMA and Swissmedic via their respective portals. Our team can support with:
- Late-stage designation strategy and post-designation amendments
- Orphan designation strategy and feasibility assessment
- Application authoring for EMA and Swissmedic
- COMP interaction and response management
- Post-designation maintenance and protocol assistance fee waivers
Clinical Study Report Production (CSR Production)
Our consultants write, review and complete clinical study reports for submission as part of CTAs, MAAs and standalone regulatory packages. We maintain strict confidentiality of your clinical study results and product information, and we deliver to agreed timelines with full review and targeted QC.
Given the nature of this work, we will need access to full datasets, data analyses and source information for specific sections.
Why Pharma Design?
Working with Pharma Design as your regulatory affairs consultancy gives you:
- Senior-level regulatory expertise at every stage of clinical development
- 15+ years of MAA submission experience across EMA, MHRA and Swissmedic
- Practical, pragmatic guidance designed around biotech timelines and budgets
- Coordinated support across CTA, MAA, PIP, orphan designation and scientific advice
- An impartial, independent view of your regulatory programme
Our Areas of Expertise
Our consultants have hands-on regulatory experience across:
- Oncology
- Rare diseases and advanced therapies (ATMPs)
- Psychiatry and neurology
- Ophthalmology
- Cardiovascular disease
- Infective diseases
- Immunology
Speak to a Regulatory Affairs Consultant
If you are planning a CTA, preparing for MAA submission, or need support with scientific advice, paediatric or orphan applications, we’re here to help.
Call us on +44 75579 83864, or complete our online enquiry form and one of our consultants will be in touch within 24 hours.
Our Values
The value we bring to pharmaceutical companies falls into four main areas:
- Objective, impartial advice tailored to your needs
- Help cut your development costs
- Help reduce your time to market
- Keep your drug on the market