Pharmaceutical Expertise at Your Service

Market Analysis

We provide product, market and country analysis across Latin America in the fields of pharmaceuticals, health care and veterinary products. Our clients usually use these reports to assess market opportunities prior to product registration or signature of licensing and distribution deals. We also offer custom made client profile evaluations of potential partners across the region.

Commercial Services

We offer commercial intermediation with a commission based on success. Our support includes but is not limited to: partner evaluation, contract management and negotiation, registration follow up, forecasts and account management during the commercial phase.

Regulatory Support

Our regulatory team of experts will assist our clients in the understanding of the different regulatory environments in each market identifying gaps in the pharmaceutical product dossiers prior to product registration and will assist you during the registration process until the Marketing Authorization is obtained.

Pharmaceutical Product Documentation Support:

• • Pharmaceutical product dossiers
• • Evaluation and/or updating of existing documentation
• • Preparation of Quality Overall Summaries
• • Stability protocols and reports
• • Management and coordination of stability studies
• • Implementation of guidelines and Standard Operation Procedures for stability studies
• • Translations (English – Spanish) of product dossiers, manufacturing instructions, SOP documents and Analytical methods

Technical Support

We offer custom made technical support in R&D , manufacturing processes, quality control methods and training.

Every project is different, and we tailor our services to suit the specific needs of each client.

Technology Transfer Projects

We offer technology transfer support for specific Biotech products, injectable drugs & aseptic processes. In order to conduct a successful technology transfer, we will assist our clients to define the right phases, key steps and critical points

APIs & FDFs Sourcing

We offer high quality APIs and FDFs for the pharmaceutical industry according the highest international quality standards. Our suppliers are all GMP certified and comply with the highest standards in the industry in terms of manufacturing, quality systems, regulatory documentation, packaging, storage and transportation.

We covered the following APIs and FDFs categories:

There’s a list of the more common products below. However, there are more, and the list keeps changing. There is also a wide range of vitamins, excipients, herbal and health products available.

All the APIs we supply are analyzed according to International Pharmacopoeias or in-house methodologies (in case they are not codified). We supply the corresponding documentation according to international regulatory requirements.