Time Frame Global Consulting
Your trusted regulatory service provider for seamless market access
Whether you are new to the KSA market or seeking to expand your product portfolio, Time Frame Global Consulting is committed to delivering tailored solutions that ensure smooth market entry and continued compliance with Saudi regulations. Our expert team is dedicated to optimizing your path to success in the Kingdom’s dynamic regulatory environment.
ABOUT
Time Frame Global Consulting (TFGC) is a premier consulting firm based in Riyadh, Saudi Arabia, specializing in regulatory affairs and market access for manufacturers in the medical device, cosmetics, animal feed, healthcare, and pharmaceutical industries. We serve as an authorized representative for manufacturers seeking approvals from the Saudi Food and Drug Authority (SFDA), navigating the complexities of both pre-marketing requirements.
With a deep understanding of Saudi Arabia’s regulatory landscape, TFGC has successfully guided over 100,000 product registrations across a wide range of sectors, including medical devices, in-vitro diagnostic devices, contact lenses, laser surgical equipment, and drug products. Our expertise spans across all product classifications and jurisdictions, ensuring compliance with the latest standards and regulations.
MISSION
Our mission is to help our clients navigate the complex regulatory landscape and bring their products to market in a timely and compliant manner. We are dedicated to providing expert guidance and support to companies. We strive to build long-term partnerships with our clients, and to provide them with the tools and knowledge they need to succeed in a rapidly changing regulatory environment. By staying up-to-date with the latest laws and regulations. We are committed to helping our clients bring innovative products to ther market and to be a trusted partner and a valuable asset to their success.
VISION
Our vision is to be the leading regulatory affairs consultancy in Saudi Arabia, helping our clients bring their innovative products to market. We aim to provide our clients with the highest quality services and expert guidance, and to be a trusted partner in their success. We strive to stay at the forefront of the industry, and to continuously improve our skills and expertise. By working closely with our clients and building long-term partnerships, we aim to make a positive impact on the industry
VALUES
we are committed to upholding the following values: Expertise: We are dedicated to continuously improving our skills and knowledge, and to staying up-to-date with the latest industry laws and regulations. Integrity: We are committed to acting with honesty and integrity in all that we do, and to building trust with our clients and partners. Professionalism: We strive to provide the highest quality services to our clients, and to conduct ourselves with professionalism at all times. Excellence: We are committed to excellence in all that we do, and to going above and beyond to exceed our clients' expectations.
SERVICES
Regulatory Affairs Services
- Development of regulatory strategies
- New registrations (Drug, Veterinary, Herbal & Health, Medical Devices, Non-medical devices, Cosmetics, Food, Animal Feed, Pesticides)
- Product classification
- Life cycle management (Renewals/variations). Preparation and compliance review of SPC, PIL, Label/Mock-ups
- Local serialization and aggregation
Health Organization Conusltaion Services
- Compliance framework ensuring the highest standards are met through expert engagement, dedicated tools, thoughtful protocols and trained professionals
- Solving unexpected challenges arising in a firm by using a comprehensive framework with the latest methodologies available in the marketplace
- In-depth engagements and fulfillments by our team to perform the required projects (PMP)
- Offer expertise in survey development allowing for proper insights in targeted populations for the objective to deliver the necessary care
- Knowledge in KSA, MENA and US health care marketplace to gain quick and efficient industry insights, especially in technology and regulatory policy
- Ability to integrate health care systems and processes strategy, technology, revenue, performance, finance, sustainability- with pharmacy, clinical operations, government agencies, insurance provider strategies, delivery systems and medical technology
- Offer a consultations in organizing firms with proper hierarchical charts, KPI’s, scorecards, and dashboards for enhancing quality of care
- Offer a consultations in organizing firms with proper hierarchical charts, KPI’s, scorecards, and dashboards for enhancing quality of care
- Expertise in translating the macro- and micro-economic forces that affect the health care industry and how to respond to it in a timely manner
- Institutional excellence for healthcare organizations
Industry Affairs Services
- Feasibility studies including Market Study and Technical Study
- Technology Sourcing: to help our customers in sourcing technologies for various APIs, Biotech Products and Finished Dosage Formulations
- Setting-up Pharmaceutical Facilities in accordance with cGMP of national regulatory authorities
- Procurement assistance to suggest the best equipment, machinery, and system with the right blend of economy and quality
- Project and Construction Management
- Qualification and Validation Services
- Preparation of STANDARD OPERATING PROCEDURES (SOPS)
- Strategic, Technical, and Advisory Services
Business Affairs Services
- Include a broad range of Business development, Marketing Access, Marketing holder and Pharmacoeconomics activities, and often define these practices quite differently through providing information, solving Problems, effective diagnosis, recommending actions, implementing changes, building consensus and commitment
Strategic Services
- Strategic assistance in Pharma Regulatory filing
- Support in Outsourcing Manufacturing or Testing Laboratories for Clients
- Support in Outsourcing BA/BE study centers
Advisory Services
- New access to the market
- cGMP (current Good Manufacturing Practice) compliance and audits
- Advisory services to queries pertaining to pharma GMP, GLP, QA and regulatory affairs
- Compliance audits as per current and updated statutory pharma regulations
- Critical Review of Dossiers
- Drug price evaluation
- Patent related issues
- Distributor contracting
- Warehouse leasing
Technical Assistance Services
- Preparation of Drug Substance and Drug product registration dossier
- Dossier Preparation & Submissions in CTD/eCTD (drug registration) to different Health Authorities
- NeeS [Non-eCTD electronic Submissions (NeeS)] formats to different Health Authorities
- Drug Firm Establishment Registration with different authorities
- CMC technical writing
- Site Master Files
Pharmacovigilance
- PV systems development and documentation
- QPPV services
- PV compliance services
- Adverse events reporting
Medical Devices
- Preparation of Technical Documentation
- Product Approval Requirements
- Device Registration
- Licensing services
- Vigilance services
- Unique Device Identification (UDI)
- Post Market Surveillance Plans
- Post Market Clinical Follow-up Plans
Other Services
- SABER-RELATED SERVICES
- FASAH-RELATED SERVICES
- IBRCS-RELATED SERVICES
- IMPORT & CLEARANCE SERVICES