Our Services
Before the initiation of the registration procedure,
we offer these services.
Our Services
Brokering & Regulatory affairs
We facilitate short-, and long-term business relations between public and private market wholesale distributors and foreign suppliers, mainly manufacturers in nontraditional purchasing markets.
BROKERING SERVICES
We perform all activities in relation to the purchase and supply of medicines for human use, except for wholesale distribution.
We negotiate independently and on behalf of our partners in relation to the sale or purchase of a product. We facilitate short-, and long-term business relations between public and private market wholesale distributors and foreign suppliers, mainly manufacturers in nontraditional purchasing markets.
By lowering legislative and regulatory thresholds for pharmaceutical manufacturers. Particularly manufacturers of high volume/value NDL-pharmaceuticals operating in for Suriname nontraditional purchasing markets. METAMEDPHARMA wants to prevent fragmentation of the relatively small Surinamese import market, create economies of scale, and increase affordability and availability of medicines and medical devices.
REGULATORY AFFAIRS SERVICES
The registration procedure can be complex. We offer assistance during the complete process.
PRE-AUTHORISATION
Before the initiation of the registration procedure, we offer the following services:
- Documentation assessment in view of registration procedure readiness,
- Assessment of commercialization,
- Giving opinions on the possibility of registration of the medicinal product, together with choosing the procedure/application type,
- Preparation for national and CRS procedures,
- Active communication with national Competent Authority
- Verification of package leaflets and mock-ups/specimens for compliance with national requirements,
- Proofreading of mock-ups in line with national requirements
REGULATORY AFFAIRS SERVICES
The registration procedure can be complex. We offer assistance during the complete process.
HANDLING OF THE REGISTRATION PROCESS
METAMEDPHARMA offers full-range support for registration procedures:
- Submission of the dossier to Suriname’s national registration agency and CARPHA,
- Active monitoring of Suriname’s and CARPHA registration procedures,
- Full support during communication with national competent authorities and CARPHA,
- Preparation of responses to the deficiency letters,
- Coordination of registration procedures.
REGULATORY AFFAIRS SERVICES
The registration procedure can be complex. We offer assistance during the complete process.
POST-AUTHORISATION
After medicinal drug product approval, we can support the maintenance and Life Cycle Management of your products, including:
- Variation submissions,
- Preparation of documentation for the purpose of renewals or withdrawals,
- Annual fees monitoring,
- Communication with Competent Authorities,
- Ongoing tracking of changes in legislation, guidelines, and procedures.
OBTAINING OTC STATUS
Submissions for obtaining OTC status for registered medicinal products (variation). OTC products are more easily available for patients.
Phone
(+597) 1234567
Location
Paramaribo
info@metamedpharmanv.com
Office Hours
M-F: 8am – 4pm
S-S: Closed