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Pharmaceutical Regulatory Affairs
In addition to product import and distribution,Kal Pharmaceuticals Plc offers related services as below:-
We have highly experienced regulatory affairs staff and provide services for the medical and pharmaceutical manufacturers.
Kal Pharmaceutical’s regulatory affairs professionals assist companies on regulatory requirements of their pharmaceutical and medical product development programs.
We provide our suppliers with:-
✓ Dossier/submission preparation or review and filing
✓ Development of regulatory strategy for the product’s life cycle
✓ Consideration of international regulatory requirements
✓ Meeting international filings
✓ Revision of plans as guidelines change
✓ Facilitate interaction with regulatory agencies, such as in meetings and conference calls, negotiations during development stages, submissions and ✓ submission approval process
✓ Liaison with regulatory agencies on regulatory, Chemistry, Manufacturing and Controls (CMC), clinical and toxicology matters
✓ Respond to regulatory agency questions
✓ Regulatory classification of products across different jurisdictions
✓ Provide expert regulatory CMC compliance advice throughout development
✓ Work with Sponsors and regulatory authorities through the resolution of complex development issues
✓ Act as Ethiopian Representative for submissions
✓ Assist with due diligence activities for investors/licensees
✓ Scientific and medical writing services
✓ Regulatory electronic submission publishing services
Local Agent for International Bids
We extend step to step Bid Assistance Services for our suppliers in Ethiopia where they do not have local presence.
✓ We provide our suppliers with Bid Consultation & Facilitation Service (Complete step to step Groundwork for Bidding)
✓ Procuring Bid Document from Tendering Authority and making it available to the client on time.
✓ Submission of Proposal/Bid on time and its entirety, with logistical assistance required to carry out the same.
✓ Represent client at the Pre-bid conference.
✓ Ensure that client organization is compliant with local bidding processes, with the respective tendering authority.
✓ Attend Bid Opening meetings on client’s behalf and report back the summary and key actions required by them.
✓ Coordinate receipt of key bid requirements like Bank Guarantee, Earnest Money and other vital documentation.
✓ Follow-up & liasioning with the Tendering Authority on client’s behalf.
✓ Giving Local Taxes and duty information & helping with local registrations if any required for the project.
✓ Assistance with complete Local Logistics.
Clinical based promotion and marketing services
✓ Market research
✓ Business intelligence
✓ Customer surveys
✓ Business development
✓ Product pre-launch & launch
✓ Re-positioning
✓ Branding/re-branding
✓ Marketing strategy plans
✓ Sales strategies
