- AgRay experts have over 20 years experience to complete your process from intermediate to full API.
- We have the expertise to implement manufacturing processes from early stage to intermediate and final finished product.
- A complete end to end support can be provided from lab to registeration.
CLINICAL & QUALITY MANAGEMENT
- On site and off site GMP mock audit based on EU standards
- Clinical trial designs & project managemnt
- Scientific advice and health authority meetings
- Medical writing and literature search
- Bio-equevalent studies
REGULATORY To MaRKET
- eCTD data dossier coversion
- Dossier GAP analysis
- Full dossier writting
- User readability testing of PIL
- Regulatory strategy advisory
- Market authorisation submission
- Lifecycle maintenance
- Regulatory attairs project outsourcing
API & Finished dosage licensing brokerage
Most pharmaceutical companies have their in house business development experts in charge of overseeing product in and out licensing. We are able to step in and bridge the gap between drug manufacturers and major distributors.
- We know where your products are needed.
- We advice our partners on the viability of your products in their respective markets.
Lincensee will be provided variety of viable products based on their local maket demand.
Business development & emerging market access
AgRay have partnered with on the ground companies in different geographical regions to provide unmatched penetration into market that are still alien to European and Asian based pharmaceutical companies.
- We understand the market
- We know the market demand strength
- We have established contacts to tap into, at a moment notice.