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Our services
Pharmaceutical manufactures with flexible support services and strong technology platforms.
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R&D
Laboratory
Bottling
Warehouse
Sofgen offers
Complete formulation
R&D SERVICES
At Sofgen Pharmaceuticals we work
with the efficiency, quality and flexibility
to develop and unleash the power of your ideas.
With an in-depth knowledge on development services, our experts are driven by science and technology that
can solve any formulation challenges
along the way.
Our services include:
Development of novel patentable formulation.
Solubility Screening.
Fill formulation development:
Solution, suspension, self emulsifying drug delivery systems, lipid-based drug delivery systems and controlled release.
Gel formulation development.
Gel/Fill compatibility study.
Small-scale encapsulation early development and fin formulation selection follo Quality by Design(QBD) cG Clinical Supplies manufacturing and packaging.
Support and value
during all stages
Our Team works closely with our customers to
understand expectations
and develop a regulatory strategy that guarantees the best quality, timely submissions, and faster, positive registration outcomes.
We also count with
experience preparing submissions in eCTD Format, and provide support
during the application phase and beyond, including annual reports and other post approval submissions.
We have proven expertise in
technology transfers, product launches, product development
and manufacturing technologies.
Success in
developing
precise
analytical
methods
Our success in
developing precise analytical methods and delivering unmatched quality
in routine analytics, gives us experience that is vital to the success of your project Integrated analytical capabilities, mixed with top-of-the-line equipments, and scientific expertise.
Analytical testing
Analytical method development, validation, and testing.
Validation of Swab Methods for Cleaning Verification
Batch/lot release testing for APIs, raw materials and formulated drug products.
Stability testing
(to support formulation development, preclinical, clinical and registration activities)
Compendia testing of raw materials.
Microbiological analysis.
Analytical
instrumentation
HPLC (High Performance Liquid Chromatography)
LCMS
Gas Chromatography
Dissolution (Apparatus I, II, III, IV)
UV-Vis Spectroscopy
FTIR (Fourier-Transform Infrared Spectroscopy)
TLC (Thin-Layer Chromatography)
Karl Fischer Viscometer Polarimeter Refractometer Density Meter
Engineers with
more than
40 years
of experience
Extensive experience with
the technical knowledge
to manage every aspect you require. Our team of engineers offer comprehensive services based
on cost, flexibility and customer experience.
Our bottling capabilities include
Offering
integrated
pharmaceutical
WAREHOUSING
SERVICES
Receiving - Storage - Distribution
Capabilities and Services
FDA approved Manufacturing and Storage facility.
Quarantine Warehouse containing GMP / Non-GMP Pallet Locations.
Large Released Warehouse containing Material Pallet Locations.
24-hour Alarm Service for site monitoring.
Cold Storage Capability.
Environmental monitoring and recording of temperature and relative humidity.
Advanced Camera Network with DVR.
Specialized
Warehouses
And Store
Facilities
for various pharmaceutical products,
including temperature-controlled.
Inventory Control, Audit, Cycle count, Variance.
Reports with Reconciliations.
Secured Storage Capability for Controlled Substances.
DEA secure storage location in the Quarantine Warehouse.
Segregated cages are in quarantine warehouse for On-Hold and Rejected materials.
Future Warehouse Optimization plans to allow additional pallet locations in Quarantine and Released Warehouses
GET IN TOUCH!
We are happy to
get in contact with you
and find the best solution for your needs.
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