Industrial Affairs
• Carry out all studies and activities for the execution of industrial projects in the fields of human and veterinary medicines, food supplements, medical supplies, cosmetics, disinfectants, detergents, air fresheners, food, children’s food, athletes, medical food and other pharmaceutical, health and medical products.
• Consulting and providing one stop services for production startups:
- Process (Compounding/filling, primary packaging, weighting/dosing, granulation/mixing, material and personal flow, production logistics)
- Building/Clean Room (hygiene zone concept, cleanroom design and equipment, clean and black media, lab furniture and equipment, airlock systems, cleanroom monitoring)
- IT/Automation (consultation and implementation or ERP, Material flow control, process control)
- Qualification (validation masterplan, DQ/IQ/OQ support, risk analysis, qualification of cleanrooms, process equipment)
• Consulting in Concept design, planning, implementation and qualification of pharmaceutical projects.
• Preparation / review of the preliminary designs and the report of the foundations of the design, preparation / review of the final drawing
• Preparation / review of environmental studies as well as studies of occupational safety and health
• Supervision / review of the stages of implementation of the industrial projects as well as the supervision / review of the quality system according to GMP requirements as well as the standards adopted by the International Organization for Standardization (ISO) as well as the recommendations of the ICH
• Supervision – Implementation / Audit for obtaining the necessary licenses to start the operation
• Supervision / review during operation to maintain the quality system achieved for the project and products.
• Tech transfers Projects for Finished Formulations
• Identify the right partners. • architects, construction and engineering firms, etc.
• Purchase the right materials and equipment.
• Find the right contractors/consultants to get the job done.
• Tracking project status, deliverables, scope and schedules. Leading customer conference calls, providing project updates, coordinating information flow between TCC and customers and coordinating resources within TCC.
Regulatory Affairs
• Over 20 years work experience in providing regulatory affairs services to all clients in pharmaceuticals/healthcare fields, and assist them at each step of the specific food products and regulatory process to manage their timely launch of pharmaceuticals, Cosmetics, medical devices in the KSA, other GCC & MENA countries.
• Good relations and contacts with SFDA, MOH, GCC office, Institutional and private hospitals.
• Evaluate information and material to ensure that it is complete and of suitable quality to be submitted to the authorities, prepare the requirements for submissions in e CTD format.
• Ability to deal with projects of any scale or length, whether on-site or remote, domestic, international, or multinational.
• Expert in Pharmaceutical products submission in SFDA, GCC, Oman, UAE, Bahrain, Kuwait, Qatar MOH and SCH.
• Providing post marketing surveillance services like ;
- For registered product or manufacturer -
- Renewal of Marketing Authorization
- Variations
- Products quality and analysis
• Obtaining SFDA special import permit for unregistered or control products
• Experience for preparing companies for regulatory inspections and is fully familiar with SFDA & GCC regulations and expectations during inspections for the following:
- Good manufacturing Practice
- Good Distribution Practice
• Pharmaceutical warehouse license services
• Clinical trial registration
Business Affairs
• Sales & Marketing operation:
- In house consultation services :
- We provide supports to already available entities by doing sales analysis, marketing plan, business plan, sales offer analysis, KPI’s implementing success and area to expand business opportunities.
- New hunting added-value companies that could be operated under TCC.
- Providing different marketing supports activity to different TCC business units.
• Local Co manufacturing Services:
- Outsourcing Provider: -
- We facilitate building contract agreement between International companies and local pharmaceutical manufacturers.
• In-Market support services:
- Cooperation services with new small to medium business helping them how to improve sales performance, how to do pricing strategy and how to increase market share.
- Offering new business extension opportunities to clients in term of improving its portfolio.
- Operation services for new startup business providing our extensive experience in pharmaceutical, Cosmeceuticals, food supplements and Medical Device business.
- Offering complete business plan and marketing plan services to different entities in Saudi market.
• Get Authorization Holders from International companies to:
- Appointing Distributors in area of assigned responsibilities.
- Operate new Business Opportunity in term of mutual agreement.
• Managing Business Development for different field (Business Development Academy)
• We provide effective concept for training that depends on ready training programs, advanced and integrated training solutions that identify needs, measure performance, follow-up development and implementing training demands for any of the Business sectors through:
- On board training
- First level staff training
- Middle management training
- Senior Business Leaders development plan
Quality Management System Services
Because Quality Matters: Tadamun is a pharmaceutical consultancy, Advisory and service provider company helping their clients to meet and apply standards.
We are delighted to offer our client with the following services:
- Building quality management system “QMS”
- Preparing clients for ISO Certification( ISO 13485 / ISO 9001/ others).
- Conducting audits (GDP& GMP audits). ➢Trainings in all pharma domains.
- Regulatory bodies’ requirements (CAPA Management). ➢Innovations to drive growth.
Tadamun group present their experience, consultancy and strategic know how for solving customers complex problems to drive innovation and transformation.
Dedicated Pharmacovigilance Services
- Provision of Local Persons for Pharmacovigilance (LPPVs) and Deputies for multinational companies
- Provision of Qualified Persons for Pharmacovigilance (QPPVs) and Deputies for Local companies
- Creation and maintenance of local PSMF or PV System Sub-Files (PSSF)
- Local Literature Screening
- Local PV regulatory intelligence / legislation monitoring
- Handling of safety reports – intake, processing, reporting, tracking
- Local implementation of aRMMs (Educational Materials, DHPC communications)
- Submission of domestic and foreign ICSRs to local Competent Authorities where required
- Local adaptation and submission of aggregate reports (PSUR, PBRER) where required
- Local adaptation and submission of Risk Management Plans (RMPs) where required
- Local safety notifications / Signals submission
- PV training for customer’s local affiliate or distributor staff
- Handling of requests and inspections from local Competent Authorities