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SPACIAL PACKAGES FOR STARTUPS
Taking your business
to the next level
Developing a regulatory strategy at an early stage of the product’s life is crucial to business success. We offer special, flexible packages for startups, that will provide cost-effective, efficient guidance that will give you the tools to plan your way to the market.
The Regulatory Basics Package includes full regulatory guidance through the requirements and submission pathways in the selected target markets, until marketing approval is gained. The package includes:
- Regulatory strategy consulting – mapping of requirements in optional markets, regulatory risk analysis
- Classifying the product and selecting the optimal regulatory path
- Identifying relevant safety and performance standards
- Creating a product Verification and Validation (V&V) plan
- Clinical strategy – defining the form and extent of clinical evaluation
- Outlining requirements for packaging and labeling, preparation / review of labeling materials
- Pre-sub meetings - preparing pre-sub files, preparing for meeting, meeting attendance, handling post meeting correspondence (as needed)
- Submission preparation and management of requests for additional information
- Presentation of the regulatory strategy & objectives for investors
- Preparation / review of the regulatory section for prospectus
The Quality Basics Package includes full establishment of an operating Quality Management System (QMS), suitable to meet the requirements of the regulations in target markets, until QMS certification is gained.
The package includes:
- QMS establishment – writing / reviewing policies and Standard Operation Procedures
- Computerized QMS – selection of a QMS software, customization of the software as needed
- QMS implementation – design control, transfer to production, process validation, supplier control, purchasing control, production control, handling complaints and CAPAs, Post Market Surveillance (PMS) and more
- Risk management – compilation / review of a risk management file
- Training of individuals / groups of employees, management training
- Audits – internal audits (off and on-site), supplier audits
- Preparation for inspection – gap analysis, evaluation of readiness, audit behavior training, audit operations (back room management, front room support / representation)
- Management of inspection findings / non-conformities, until certification is obtained
The Market Entry Premium Package includes full regulatory and quality service,
as well as product and company branding and website development.
We are using creative design and strategic thinking to
develop the assets that power brand success.
The package includes:
- Complete regulatory guidance, from strategic plan to gaining market approval (see Basic Regulatory Package)
- Complete quality system support – from Quality Management System (QMS) design to gaining QMS certification (see Basic Quality Package)
- Product and company branding - logo, brand language (colors, font etc.), brand guidelines, business card, letterhead, email signature, presentation template, LinkedIn cover and profile picture (other socials can be added upon request)
- Company and brand website - responsive (desktop, tablet, phone)