Engineered for Approval

Pre-MAA Development Strategy:

• Develop regulatory strategy for clinical trial filings in line with the evolving regulatory landscape.

• Ensure the timely and compliant filing of clinical trial applications, amendments and related documentation.

• Act as a Health Authority (HA) contact in fulfilling local obligations for assigned products.

• Support due diligence activities for assessment of new assets and market intelligence.

• Lead the preparation of Scientific Advice Meetings (SAM) with HA, including meeting requests, development of briefing pack, pre- and post-SAM debriefing and regulatory strategy execution.

• Lead the preparation of pre-submission meetings with the HA, including meeting requests, development of briefing pack and presentation during the meeting.

Marketing Authorisations (MA) - Registration and lifecycle maintenance – UK &EU:

Our team of experts provide the following services:

• Work with clients to develop and implement regulatory strategies and identify regulatory risks to determine the most appropriate route for MA submission and approval.

• Support Initial Marketing Authorisation (MAA) filings across all established routes in the UK/EU, including National, IRP, Project Orbis, and Access Consortium, ensuring alignment with all relevant legal bases.

• Support Paediatric Investigation Plan (PIP) development and submission to the HA, including initial PIPs, PIP modifications, PIP Compliance and Annual Report submissions.

• Provide post-approval life-cycle management for submissions to the HA as needed (e.g. Line extensions, variations, CMC and labelling changes, aRMMs and educational materials, PSURs and post-authorisation commitments).

• Provide review of promotional and non-promotional materials and submission of product specific educational materials.

Chemistry, Manufacturing and Controls (CMC):

Building regulatory confidence in product quality and manufacturing.

Our CMC specialists provide strategic and technical support across CTD Module 3, helping pharmaceutical and biotechnology companies ensure that their quality documentation, manufacturing processes and supporting data meet regulatory and ICH expectations.

Our services include:

• Module 3 Review & Assessment: Comprehensive CMC dossier review, compliance assessment and regulatory gap analysis.

• Pharmaceutical Development: Formulation development, dissolution performance and support for conventional, sterile and modified-release dosage forms.

• Analytical Development & Validation: Analytical method development, validation and regulatory assessment.

• Manufacturing & Process Validation: Protocol and report development, review and regulatory assessment.

• Specifications & Quality Standards: Specification development, testing parameters, acceptance criteria and monograph design.

• Stability & Shelf-Life: Stability programme assessment, kinetics, shelf-life and storage-condition justification.

• CMC Gap & Risk Management: Identification of regulatory risks and development of targeted mitigation strategies to strengthen submissions.

From development to submission, we help transform complex CMC requirements into clear, robust and regulator-ready solutions.

• Provide creation and maintenance of national product information, including SmPCs, PILs, labelling, artworks and Risk Minimization Measures (RMMs) materials .

• Ensure compliance with the Risk Management Plan, including management of additional risk minimisation materials.

• Provide advice on chemistry, manufacturing and controls (CMC), toxicology, clinical and pre-clinical product development, through to HA approval.

• Review relevant sections of the dossier to ensure compliance with the regulatory requirements.

• Support the implementation of Compliance / Gap Analysis through reviewing the current regulatory status of the medicinal product and subsequent submission of variations to ensure compliance with current standards and registrations.

• Support the preparation of responses to questions raised during validation and assessment process of applications, ensuring submission within the agreed time frame.

• Management & follow-up of post approval commitments made.

We support our clients in managing their existing MA portfolio with the following:

• Develop efficient variation submission strategies

• Renewals (preparation/submission)

• Advice on Sunset Clause Legislation

• Change of Ownerships/Marketing Authorisation Transfers

• Pre-vetting of Advertising Materials

• PIPs

• Regulatory Intelligence for multiple markets

Marketing authorisation for MENA - Saudi Arabia & Gulf states:

For companies seeking to authorise their products in the lucrative SA & Gulf markets where there is strong demand for generics, particularly those manufactured in the UK/EU, this consultancy is well positioned to support the achievement of this goal.

In taking the advantage of the experience previously gained in the regional pharmaceutical industry and build-up of a good relationship with regulatory authorities and marketing companies including wholesalers, possibly facilitated by knowledge in the local requirements, the following services can be provided:

• Reviewing the technical dossier with recommendation of amendments required to ensure compliance with the current regional regulatory & technical standards applied.

• Our projects are supported by a seasoned regulatory expert with deep experience in licensing medicinal products and a strong track record of successful regulatory submissions. Through an exclusive partnership with a leading consultancy in the field, we provide access to senior specialists who bring extensive knowledge of national

regulatory requirements and long‑standing expertise in managing MAA procedures. This team oversees the entire submission process, coordinates interactions with regulatory authorities, and ensures that every step meets the highest standards of quality, compliance, and timely execution.

• Liaising with the local marketing and wholesaler companies which are well known in the area possibly facilitated by language in assisting to reach a common understanding for future cooperation.

Elevion Pharma can help clients export pharmaceutical and related healthcare products into the Gulf region and, using a network of national representatives, distribute them throughout the Middle East and Africa.

Rare Disease Regulatory & Development:

Turning complex rare disease challenges into clear regulatory strategies.

Rare disease development requires a highly tailored approach. ELEVION PHARMA supports sponsors in navigating the regulatory, clinical and evidence-generation challenges associated with small patient populations, limited natural-history data, innovative endpoints and significant unmet medical need.

Our expertise includes:

• Orphan Drug Strategy: Orphan designation strategy, regulatory pathways and development planning.

• Early Patient Access: EAMS, ILAP, Compassionate Use Programmes advice

• Evidence Generation: Natural history, clinical endpoints, real-world evidence and innovative approaches to evidence generation.

• Patient-Centred Development: Integrating patient perspectives, disease burden and meaningful outcomes into development strategies.

• Regulatory Interactions: Scientific advice, regulatory meetings, briefing packages and implementation of regulatory feedback.

• Paediatric Development: Regulatory strategy for paediatric populations and age-appropriate development.

• Lifecycle Management: Post-authorisation evidence, indication expansion and long-term regulatory strategy.

Our approach combines scientific insight, regulatory expertise and patient-centred thinking to help bring innovative therapies to rare disease communities.