EC Innovations’ life sciences business unit has established a long-term strategic partnership with Voisin Consulting Life Sciences (VCLS). By combining ECI’s extensive experience in medical translation and localization over many years with VCLS’s expertise in pharmaceutical regulatory consulting and clinical research, we are able to provide customers with comprehensive solutions to accelerate the development and commercialization of pharmaceutical products and assist biotechnology companies, pharmaceutical companies, and pharmaceutical investors to break into international markets.
In recent years, the global life science and pharmaceutical industry has witnessed fast development and expansion. However, increasingly stringent market supervision policies have also been introduced by a number of countries. Responding to broad market demand and by sharing technological resources, professional knowledge, and industry experience, ECI and VCLS have established an in-depth cooperation to provide regulatory policy consultation, product development strategy customization, medical translation, and other services to biotechnology/pharmaceutical companies, helping companies ensure the regulatory compliance of pharmaceutical products, complete cross-border submissions, save on R&D costs, shorten time to market, and ultimately, achieve commercial success.
Services
We assist customers in formulating product application strategies for global markets to accelerate product R&D and commercialization
The challenge
- The requirements of regulators and payers as well as regional laws and regulations need to be considered as a whole to plan product development paths
- Lack of experience working with regulatory and health authorities
- Lack of internal resources and professional talent (drug policy, registration operations and technology, etc.)
Our services and strengths
Global drug policy strategies and pathways
- Integrated product development strategies focusing on key global markets
- Formulation of custom application paths
- Preparation and submission of clinical trial and product launch applications
Deep regulatory experience and extensive expertise in medical science
- Professionals with former work experience in the FDA, EMA, and other nation-level pharmaceutical regulatory agencies
- Broad experience in various therapeutic areas and relevant product expertise
Efficient communication with regulatory agencies
- Familiar with the SA consultation process with EMA and member states
- Assistance in preparing for and convening relevant meetings such as pre-IND, EOP2, pre-NDA/BLA, EMA SME
- Expedited program applications (PRIME, RMAT, BTD, etc.)
Post-launch strategy and management
- Full lifecycle management planning
- Market competition strategies
Helping customers overcome regulatory, scientific, and technical challenges to ensure that production is compliant, flexible and delivered on time
The challenge
- Operational, technical, and regulatory professionals and knowledge reserves are needed for product CMC and quality compliance
- Difficulty coordinating complex manufacturing, testing, processing, storage, and distribution processes
- Quality requirements for a product at different stages of development need to be differentiated as clinical development pushes forward
Our services and strengths
Integrated technical and pharmaceutical regulatory expertise
- Expert teams for different product types
- Variety of technical consulting services
- Extensive experience in GMP and QA compliance
Extensive corporate service experience
- Product development and lifecycle management assistance
- Preparation of application documents
- CDMO selection, audit, and technology transfer assistance
Practical solutions for complex products
- Development of targeted strategies for different R&D stages
- Solutions for reducing changes and registration revisions
- Anticipation of issues that regulators may raise and assistance in formulating response plans
Internal teams and expert resources
- Pharmaceutical regulatory and technical teams around the world ready to respond to your needs
- Access to extended expert resources for specific needs
- Assistance in fulfilling regulatory compliance requirements in various countries/regions such as Europe and the US
Integrated custom solutions for advanced therapies, from lab to clinical translation
The challenge
- Complex product characterization and supply chain management
- Complicated mechanisms of action and challenges in developing appropriate potency assays
- Difficulty developing market access strategies and demonstrating value to payers
Our services and strengths
Product development and registration
- Multi-regional product development strategies and registration path planning
- Preparation and submission of clinical trial and registration applications, including applications for country-specific GMO authorizations
- Preparation and submission of clinical trial and product launch applications, including applications for country/region-specific GMO authorizations
- Early interaction with regulators, such as INTERACT and ITF meetings
CMC
- Manufacturing process review, design, and scale-up
- Raw material quality control
- DS and DP classifications
- Development of product characterization and potency assays and establishment of release specifications
- Technology transfer
Non-clinical/clinical development
- Gap analysis for development plans
- Animal model selection
- Selection of safe starting dose for first-in-human (FIH) clinical trials
- FIH and pivotal clinical trial protocol design
Market access
- Pricing plans and market access strategy development
- Establishment of reporting path for empirical research
- Assistance preparing for and holding consultation meetings with health technology assessment agencies
Integrated registration, clinical, and compliance solutions tailored to medical devices and diagnostic products
The challenge
- Complex regulatory environments (e.g. the new EU MRD and IVDR) and pricing and reimbursement pathways for innovative products
- Difficulty formulating a global development strategy for drug-device combinations
- Difficulty determining how and when to establish an appropriate quality management system
Our services and strengths
Efficient EU MRD and IVDR support
- Custom product development strategies (including certification, classification, claims, and positioning)
- Facilitation of meetings with notified bodies and EU supervisory authorities
Deep pool of expertise in drug-device combinations
- Product positioning and application strategies
- Development of parallel product development plans
Subject-centered clinical research
- Design, implementation, and management of clinical trials involving subjects and KOLs
- Medical device vigilance system and safety case management
Quality management systems
- Establishment and maintenance of quality management systems
- Preparation of QMS documentation
- Assistance preparing for audits and holding mock inspections
- Risk and quality management assistance
Assistance maximizing the asset value of pharmaceutical products through early positioning and market shaping coupled with payer demand
The challenge
- Reduction of risks related to products not being recognized and reimbursed by payers
- Lack of experience working with payers and health technology assessment (HTA) agencies
- Difficulty convincing investors of the value of the product
Our services and strengths
Patient-centered strategy
- Assistance identifying patient groups and strengthening communication and cooperation
- Integration of patient perspectives, needs, and preferences into clinical protocols
Development of global market access strategies
- Product positioning and market shaping
- Formulation of product development programs that meet the expectations of regulators and payers
- Product value and market potential assessments
Interaction with payer institutions
- Assistance consulting with HTA agencies
- Assessments of payers' willingness to pay
- Expedited program applications (PRIME, RMAT, BTD, etc.)
Product pricing and reimbursement
- Effective communications with investors and payers
- Determination of reimbursement pathways
- Proposal of alternative pricing strategies
As your partner, we maintain close communication with the FDA to help new products obtain US market approval
The challenge
- Lack of experience in communicating with the FDA and unfamiliarity with the complex pharmaceutical regulatory environment in the US and FDA requirements
- Difficulty determining the appropriate application path for the product
- Collaboration with regulatory agencies outside of standard procedures required to expedite product applications and reviews
Our services and strengths
Registration applications and communication
- NDA/BLA preparation and submission
- Assistance with all types of communications, e.g. pre-IND, INTERACT, meeting types A, B and C, and other special meetings related to drugs and medical devices
FDA fast track program
- Assistance evaluating, preparing, and applying for various FDA fast-track programs (RMAT, BTD, FTD, and PRD)
Clinical application submission and management
- Assistance preparing and submitting IND-related materials
- Patient-centered protocol writing
- Clinical research monitoring and project management
- Overseeing and managing clinical risk assessments
Post-launch lifecycle management
- Registration maintenance and compliance management, including changes, amendments, re-registration, supplements, and annual reporting
Beginning with the end in mind, we keep in close contact with regulatory agencies and are committed to providing customers with comprehensive solutions for a successful launch
Inter-disciplinary project team
Internal expert teams covering pharmaceutical, non-clinical, clinical, market access, and pharmaceutical regulatory affairs
Comprehensive clinical research services
Delivers efficient, data-driven, patient-centered clinical research
Extensive experience working with regulatory authorities
Professionals with previous work experience in regulatory agencies such as FDA, EMA, MHRA, and ANSM
Large professional knowledge pool
Specialized in various innovative products, including cutting-edge cell and gene therapy products, digital health technology, and microbial products
Information Security
We are deeply aware of the importance of confidentiality and do our utmost to ensure the security, confidentiality, and integrity of customer documents and communications.
- Project documents are protected by adhering to strict procedures and guidelines throughout the project process.
- All project personnel are required to sign a non-disclosure agreement.
- We have passed all customer security audits, including global audits by multinational corporations.
- We have achieved ISO 27001 information security management system certification.
- Multiple data encryption technologies are adopted when transmitting data.
- Reliable backup, disaster recovery, and data recovery mechanisms in place.
About VCLS
Voisin Consulting Life Sciences (VCLS) is an international pharmaceutical regulatory and clinical research consulting company dedicated to helping customers bring innovative drugs and medical products to the market more quickly to benefit patients. VCLS provides a full range of services and custom solutions for entry into overseas markets, including pharmaceutical regulatory consultation, registration applications, market access strategy analysis, pharmaceutical, non-clinical, and clinical research planning, and clinical trial operation management.
We appreciate your interest in EC Innovations.
Do you wish to learn more about EC Innovations’s language services solution?
Please provide information about your business so that we can handle your inquiry more efficiently. All the information you provide will be kept strictly confidential.
