Product development and troubleshooting services.

Our highly experienced and specialized in cGMP, FDA, EU compliance and R&D products development team provides a comprehensive range of R&D and troubleshooting services:

Regulatory Affairs Service:

Registration files preparation for MENA region according to target market regulations and current guidelines

Preparation of Common Technical Document format (CTD) files for EU and US markets.

Drug Master File preparation

Product development and API purchasing system services according to current guidance's:

API Purchasing system service: 

API Supplier approval system evaluation according to GMP, EU, FDA, MENA  Market, and CTD format requirements

Dealing with new alternative supplier for API according to current GMP, EU,  FDA,MENA Market , CTD format requirements

Preparing list of approved API suppliers for active and Inactive raw materials

API Drug master files evaluation according to current guidelines and according to the target market ( EU, CTD format, FDA, MENA market )

Setting specification for API according to current EP, FDA guidelines

Evaluation of API suppliers Certificates of Analysis

Standard procedure for raw materials requisition of orders.

Revision and develop all related API system SOPs

Raw material troubleshooting and preformulation studies service:

Preparing pre-formulation studies (Theoretically and Practically), including full studies for API

Standard procedure for working standard preparation according to GMP

Methods for Detection for API polymorphism and polymorphism   selection to avoid finished product problems related to polymorphism properties, polymorphism trouble shooting

Dealing with pharmacopoeial Reference standards, and standard procedure for storing and handling

API quality Evaluation according to chemical and physical properties

Setting specification for active and inactive ingredients according to Eu, FDA, GMP

API certificate of analysis preparations according to EU-GMP and US-FDA requirements 

 Particle size analysis and evaluation for micronized API using laser particle size, results evaluation, and trouble shooting.

Physical properties of API (Flow-ability, Density, Compressibility, Crystallinity, and Polymorphism) effect on manufacturing process.

Compatibility studies of active material with selective excipents related to the proposed formula and troubleshooting  

Revision and for all related SOPs system and establishing new required SOPs according to system requirements

Evaluation of labeling system

Withdrawing raw materials from store

Product Development service:

Comparative Dissolution Profile requirement and evaluation according to Bioequivalence studies requirements according to the target market, and brand drug selection  

Evaluation of proposed formula according to selective excipents and comparative profile results and troubleshooting,

R&D Product Development File preparation according to target market (Gulf, Jordan, MENA market, Eu.FDA)

Stability data evaluation for accelerated and long term studies according to current guidelines

R&D documentation system evaluation

SOP Preparation

Ready finished product dossiers service:

Which includes of supporting the pharmaceutical companies with ready finished product dossiers according to GMP, EU, and CTD formats. The dossier consist of:

Bioequivalence studies

Full manufacturing process,

API specifications, control test and certificate of analysis 

Finished product specifications and control test,

Formula composition and exceipents used.

Exciepents specifications and certificate of analysis

Validation of analytical methods

Stability Results for accelerated and long term studies

Finished product Certificate of analysis

Packaging material

Impurity Profile