Our services

Driven by Science & Innovation, we offer our customers a full range of services during all key points of the development process

Sofgen offers Integrated R&D SERVICES

At Sofgen Pharmaceuticals we work with the efficiency, quality, quality, innovation, and flexibility to work with your most challenging projects.

With an in-depth knowledge of development services, our experts are driven by science and technology to solve any formulation challenges and requirements through all stages.

Some of our R&D 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.

Laboratory Services

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

Bottling

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

Warehouses

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!

Schedule a meeting with one of our experts and visit our US site.

LET'S DO THIS