ABHC
Services
What we do & How we do it
Representing Companies
ABHC represents companies in the market to register their products, to participate on National and international Tenders and ABHC can be your MAH for African markets.
Registration
- Filling new, renewal, variation (changes) of pharmaceutical, medical device and food dossiers as per the requirements of agencies.
- Follow up registration status for already filed applications.
- Share regulatory changes and updates.
- Design regulatory strategies
- Solve regulatory issues on importations, labelling, purchase order, expiration of validity of MA and others.
Pharmacovigilance:
- Assign PQP, act as PQP.
- Develop tools to record adverse events report received from health professionals and report to the manufacturer.
- Develop tools to record PSUR, DSR and RMP and report to the manufacturer and HA as needed.
- Support in post market surveillance.
Clinical trial:
- Review protocols as per countries requirements
- Link CROs and new clinical trial centers.
- Facilitate importation of investigational products (IPs)
Good manufacturing practices
- Do pre regulatory authorities audit to give confidence and support manufacturer not to waste time if not as per the GMP requirements of countries
- Support new companies to apply for GMP audit by countries Regulatory agencies.
- Support companies from SRA regions to apply for GMP on site audit waiver.
- CAPA Review for those not comply to cGMP audit by regulatory agencies and re- apply for audit.
local manufacturer
- Establishment layout review
- API sources/Vendor linking
- Avail Locally manufactured product list
- Update with list of products protected for local manufacturers
- Support with the benefit packages of local manufacturers
- Do feasibility studies for new entrants
Good Distribution practices
- Develop procedures, working instructions and SOPs
- Do audit and reccomend on storage conditions and transportation as per the requirements of agencies
- Arrange disposal of expired products
- Do warehouse audit as per international standards.
Are you looking for a partner
to bring your product to
Ethiopian market?
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