SERVICES

Strategic Advice

Understanding our clients’ challenges is the basis of what we do. We focus on listening and brainstorming before creating strategic solutions, offering advice, and preparing quality plans that meet your desired objectives.

Strategic advice is critical in regulatory, as it’s often used to decide which filing option is most appropriate for a particular development or product. It also frequently involves having clients obtain scientific advice for regulatory and HTA requirements as early as possible in the development cycle.

However, a strategy is only as successful as its implementation, which is why we always develop solid plans of action to meet project deliverables.

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SERVICES

Pharmaceutical Development

Our pharmaceutical development team has many years of experience and can support you in the following areas:

General

  • Set-up of development plans
  • Management of pharmaceutical development
  • Vendor selection and follow up of vendors
  • Support in GMP requirements for development programs, including those for investigational medicinal products and drug substances used during their manufacture
  • Interaction with competent regulatory authorities as required during pharmaceutical development (see regulatory strategy and implementation)
  • Special experience for the design of combined development programs in different regions (the EU, South East Europe and ASEAN)
SERVICES

Project Management

Our teams offer project management for entire projects or individual steps, including planning, organization, partner selection, coordination, monitoring, and controlling of development processes.

More specifically, we can:

  • Define product development concepts
  • Design and implement development programs for quality, pre-clinical, and clinical processes
  • Control the various steps of the development process
  • Ensure all quality aspects are covered
  • Select, qualify, and manage vendors
  • Prepare, control and monitor budgets
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SERVICES

Regulatory Strategy & Implementation

Regulatory has been the core of our business from the start, and over the years we've developed an experienced team who pride themselves in helping clients not only with strategy, but also with implementation, a key component to successful commercialization.

Regulatory Strategy & Management of Drug Development

  • Provide regulatory advice in the early phases of development projects
  • Define the product’s concept
  • Interpret regulations and guidelines
  • Develop strategies for technical aspects of drug development (quality, pre-clinical, and clinical)
  • Design and manage drug development programs
  • Determine market access requirements and develop strategies in the early phases
  • Identify and manage external resources/experts
SERVICES

Pharmacovigilance

Our pharmacovigilance team helps you manage and monitor all safety aspects of your product or device so that it meets the required regulations. Our services include:

  • An EEA-qualified pharmacovigilance specialist
  • Local Pharmacovigilance qualified person
  • Pharmacovigilance quality system preparation and management
  • Good pharmacovigilance practice auditing
  • Post-marketing case processing management, including EudraVigilance reporting
  • Signal detection
  • Local and global literature reviews
  • Safety database management
  • Periodic safety update report preparation
  • Risk management plan preparation
  • Clinical trial pharmacovigilance services, including preparation of development safety update reports and case processing

Pre- and post-marketing pharmacovigilance project management

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SERVICES

Auditing

Our in-house auditing team, supported by local regulanet® members, assists in all aspects of auditing and provides the following services:

Third party audits

  • GMP audits for drug substances and products, including investigational medicinal products and supply chains (with special experience in Asia)
  • GMP certification application submission and liasion with EU authority
  • GDP audits for warehouses, distributors, and supply chains
  • Wholesale Distribution License Applications
  • GMP and GDP training
  • GLP audits for safety, pharmacology, toxicology, and human and animal bioanalytical studies, as well as other studies conducted under GLP
  • GCP audits for CROs, study sites, and other vendors, including central labs and drug repositories
  • Pharmacovigilance audits
  • Vendor Qualification Audits
  • Preparation of Inspections (Mock Audits)
SERVICES

Market Access

By gaining an understanding of clients’ commercial needs, key decision makers, and route to market, we recommend market access solutions that bring your products efficiently to market.

We lead, facilitate, and provide support to clients in the following areas, involving specialists when needed:

  • Product development strategies to ensure the market access, payer, and regulatory requirements are incorporated into clinical programs, e.g., the right comparators are being included and the relevant end point and outcomes are being considered
  • Liaisons with Healthcare Technology Assessment (HTA) agencies to confirm all development programs include the necessary requirements for approval
  • Development of dossiers to satisfy HTA agencies and payer requirements, e.g., value-based pricing
  • Negotiations with HTAs and insurers
  • Patient access and adherence programs
  • Local support for market access through our regulanet® network, which provides key local knowledge to successfully access markets
  • Development of route to market solutions for all types of products, including Rx, OTC, medical and biotech devices, and food supplements and cosmetics
  • Planning of route to market strategies, including assessing market potential by introducing third parties, investment partners, and distributors
  • Marketing plans, including regulatory guidance on branding
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SERVICES

Portfolio Analysis & Life Cycle Management

Through our network of contacts and knowledge of dossiers, we offer you the following services:

  • Portfolio and business strategies
  • Portfolio analysis and management, including process implementation
  • Product portfolio completion via licensing in/out and partnering/gap filling
  • Product launch facilitation
  • Post-launch life cycle management
  • Supply chain management
SERVICES

Due Diligence

Our cross-functional team offers a wide variety of due diligence services in mergers and acquisitions, and is carefully selected to investigate and deal with requirements in your countries of interest.

Our services include reviews and assessments of:

  • All regulatory matters, including dossiers and their potential
  • Regulatory resources (staff, equipment, and expertise)
  • Product supply, including GMP aspects and audits
  • Product portfolio and pipelines (gaps, competitors, development plans, etc.)
  • Product portfolio continuation and valuation
  • Risk/opportunity assessment for product portfolios
  • Market access to other territories
  • Growth strategies
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SERVICES

QM Systems And Licenses

Whilst the process of obtaining Marketing Authorization for a medicinal product in the EU is well harmonized, the quality management system and license requirements for companies handling medicinal products (manufacturing, import, distribution etc.) differ considerably between EU member states. The requirements depend mainly on the specific set-up between the involved companies and the ownership of products at the different points in time.

Achieving an optimal quality system, which fulfills EU country specific requirements and fits to your company internal strategy and processes, is mandatory for successfully achieving the required licenses and enhancing a high internal compliance. Our team, involving local expertise where necessary, supports you with any service that will benefit your existing or intended system, be it for gaining a wholesaler or import license, establishing a system or fulfilling GMP requirements.

Our services include:

  • Background information on the system and license requirements in the EU member states
  • Strategic advice on the optimal solution for your company
  • Complete system set up or adaptation of your existing system for a principal with several subsidiaries in several EU member states
  • System set up or adaptation of your existing system for a single company in one EU member state
  • Support during implementation of your system
  • Training
  • Compilation and submission of applications for the required licenses including follow up with the authorities
  • Mock inspections and support during inspection preparation
  • Support during inspection
  • Support during follow up of authority inspections until granting of the intended license(s)