--- title: "Regulatory Affairs for Pharma & Biotech | QbD Group" description: "Navigate complex global regulations with confidence through expert guidance across the full product lifecycle. We help you accelerate approvals and maintai" url: https://qbdgroup.com/en/services/regulatory-affairs-services-for-pharma-biotech type: "Page" language: en publisher: "QbD Group" citation: "QbD Group, \"Regulatory Affairs for Pharma & Biotech | QbD Group\", https://qbdgroup.com/en/services/regulatory-affairs-services-for-pharma-biotech" --- # Regulatory Affairs for Pharma & Biotech Your regulatory partner across the full pharma lifecycle Navigate complex global regulations with confidence through expert guidance across the full product lifecycle. We help you accelerate approvals and maintain long-term compliance. Global RA Solutions ## QbD Group: your regulatory affairs expert We support life sciences companies across the full product journey — from early development to post-market — with integrated, end-to-end consultancy services. ### End-to-End Regulatory Support From early strategy to post-authorization, QbD covers every milestone with integrated support, ensuring continuity, compliance, and faster market access. ### Recognized Expertise With a proven track record since 2011, our team is trusted by clients and authorities, delivering reliable dossiers and efficient agency interactions. ### Integrated Pharma Capabilities Bringing together Regulatory Affairs, PV, Toxicology, QA, and Clinical expertise — along with EU import and IMP/product batch release capabilities — QbD ensures every critical function aligns with regulatory requirements. ### Flexible Partnership Solutions Whether you need support for a single submission or a full RA function, we act as an extension of your team, providing efficiency, transparency, and long-term alignment. Experience 350+ National procedures Successful registration processes 250+ Global registrations European/global registration procedures 75+ Agency interactions In the last 3 years 360+ ASMF assessments Reviewed for registration readiness 950+ Development programs Successfully supported Team & Expertise ## QbD Group team & expertise Our Regulatory Affairs strength comes from a **70+ team of consultants** located across Poland, Spain, the UK, and Belgium, providing pan-European coverage with strong local insight. Beyond EU and US expertise, we offer **specialized UK regulatory know-how** — essential post-Brexit for navigating both EU and UK pathways. Our team's backgrounds span academia, pharma, biotech, and CMOs/CROs. Strong **GMP capabilities for IMPs and commercial material** allow us to align development, quality, and regulatory strategy to accelerate approvals and ensure compliance. 70+ Qualified Professionals Life Science BSc, MSc & PhD Pan-European Coverage Strong GMP Capabilities Full Lifecycle Coverage ## We cover the full life cycle From early strategy to post-marketing compliance — ensuring faster approvals and sustainable compliance at every step. ### Plan Ahead - Regulatory due diligence - Global regulatory strategy - Global regulatory gap analysis - Programs to support and expedite global development - EMA: SME status, ODD, CAT designation, PRIME - MHRA: ILAP, PIM/EAMS, ODD - FDA: ODD, FTD, BTD, RMAT ### De-risk & Enhance - Drug development plan: Clinical, nonclinical, and CMC - Pediatric plans in the EU, UK, and US - Agency interactions (EMA, MHRA, FDA) - EMA: ITF, Scientific Advice, Protocol Assistance - FDA: INTERACT, Type A, B (incl. pre-IND), Type C & D meetings - HTA interactions ### Clinical Trials - Clinical protocol & PIPs/PSP - Regulatory documentation: IB, IMPD, IND - Clinical trial applications in the EU, UK, and IND in the US - Clinical safety: DSUR, PV services - IMP GMP services ### Marketing Authorization - Strategy & storyboarding (submission narrative & roadmap) - Regulatory gap analysis and scientific review - Pre-MAA readiness - CTD Authoring (Modules 1–5) and eCTD publishing - MAA: EU, US, and UK - Translations & linguistic quality assurance - ERA reports ### Post-Market - Renewals, Variations (Type IA/IB/II) & OTC switch - Periodic safety updates (PSURs/PBRERs) - MA transfers, portfolio transitions & M&A support - Promotional & non-promotional material review - Regulatory intelligence - RIMS implementation & management - IDMP / SPOR - review, assessment & implementation Our Approach ## Approach advantages We offer broad capabilities with the focus of a specialized partner. From regulatory strategy and scientific advice to Marketing Authorization authoring and lifecycle maintenance, our senior-led teams deliver tailored, compliant solutions—without the overhead and rigidity of larger providers. ### Tailored regulatory solutions We tailor our support to your size, stage, and strategic objectives, optimising resources while ensuring rigorous compliance throughout development. ### Flexible in workload We adapt to your needs and company size—stepping in only where we add value, whether through one-off support, ongoing outsourcing, or targeted expertise. No project is too small or too complex. ### Speed and reliability in submissions With optimized processes embedded across the full development program, from authoring to publishing and submissions, we deliver predictable timelines and lower the risk of delays. ### Agile, collaborative partnership As an extension of your team, we bring flexibility and clear communication to deliver practical solutions that keep your development moving ahead. Why QbD Group ## Your trusted partner QbD Group's Regulatory Affairs team combines deep industry expertise with a pragmatic, hands-on approach. We help life sciences companies navigate complex European regulatory landscapes efficiently — from initial strategy through post-market compliance. Cross-industry expertise our regulatory specialists cover Pharma, Biotech, Medical Devices, IVD, and Combination Products under one roof. Strategic regulatory planning we align your regulatory pathway with commercial objectives to accelerate time-to-market. Proven track record with thousands of successful submissions and dossier management projects across Europe, we deliver results you can count on. Scalable support from a single regulatory question to full outsourced regulatory operations, we adapt to your needs. ## Let's talk Regulatory Affairs From regulatory strategy to product approval, our experts are ready to guide you through every step. Contact us --- Source: https://qbdgroup.com/en/services/regulatory-affairs-services-for-pharma-biotech — © QbD Group. Quote freely with attribution and a link back.