Coordinating/Monitoring of Local Biostudies
When required, Ackerman Pharma has a team of chemists with experience in:
- Auditing bio centers
- Coordinating importation of test drugs
- Purchasing local reference products
- Coordinating and auditing the studies in-situ
- Ensuring final report and bio study are conducted according to NOM-177 (Mexican BioStudy)
Regulatory Affairs
Our team of RA specialists are experienced in assembling the following dossiers and/or filings:
- Medicines, Medical Devices (all classes), Food Supplements, Vitamin medication, Herbal products, Cosmetic.
- New molecules, generic molecules, generic biological and bio similar molecules.
- Dossier assembly, translation, technical and/or administrative changes.
- Risk Management Plans for PV (Pharmaco VIgilance and/or TV (Tecno Vigilance).
- Import permits
- COFEPRIS enquiries
Importation
Our logistics team is highly specialized to ensure all products are imported legally and with minimum delays and import duties.
Our services include coordination with customs brokers at Mexico City airport, Laredo (US/Mexico border crossing), and Manzanillo or Veracruz ports.
At an additional optional cost, we can provide security service to accompany any shipment until final delivery at Ackerman facility, and/or insurance coverage for products transiting from port of entry until Ackerman warehouse.
Our local team will handle all required import permits and broker forms required for a trouble-free importation of any registered product.
Warehousing
Our modern 1250 m2 facility is a 4PL establishment with temperature and humidity controls, and ACD restricted access.
We are fully compliant with the latest COFEPRIS distribution and warehousing norm (NOM 059 and NOM 241) updated in 2019.
In addition, Ackerman has a full Establishment License and dedicated areas to perform secondary packaging of medicines, medical devices, and samples.
Our logistics team will handle shipping, inventory management, warehousing, packaging and security of your products.
We also provide advice on how to save money on optimal inventory management by using our facility to re-pack small volume orders for markets across Central and South America that cannot buy MOQ.
Our state-of-the-art ERP allows you to monitor and control your sales, inventory, and vital commercial statistics, optimizing your cash flow investment.
Pharmacovigilance and Technovigilance
Ackerman has a COFEPRIS approved PV unit, QMS and SOP´s dedicated to comply with the latest COFEPRIS norms
(NOM 220 for PV and NOM 241 for TV).
Our goal is to help you in providing activities related to detection, assessment, understanding, and prevention of adverse effects or any other possible drug or device - related problem.
Our goal is to be compliant with the latest ICH E2A guidelines, and we currently use VigiFlow software to collect and process individual case safety reports (ICSR). Our head PV responsible holds a MsC in Clinical Investigation with a specialty in Clinical Pharmacology.
We can assist you in developing a Risk Management Plan, or if desired, we can adapt your global PV/TV procedures to ensure compliance with Mexican norm.
Distribution
Ackerman distribution network services all of Mexico, and we are constantly evolving to encompass new technologies allowing us to focus on supplier and customer relationships.
We provide transportation in accordance to latest COFEPRIS norm, as well as labeling, packing, fulfillment, order preparation, processing, shipping, receiving, performance measurement, returned goods processing, destruction of product through authorized government agencies, and any other process required for internal or external clients.
Our goal is to constantly increase accuracy and service by having efficient SOPs focused on safety, error reduction, and optimization.
Commercial
At Ackerman, our commercial team is dedicated to best practices across each function and activity.
The segments we focus on include retail, public sector, and hospital segments. We continuously assess our commercial capabilities against our competitors and strive to improve performance.
Commercial excellence is the cornerstone of our growth and success. If you need help or assistance in planning your commercial entry into the vibrant Mexican pharmaceutical market, please contact us.
