Regulatory Affairs
We provide comprehensive solutions for your company in the Pharmaceutical, Cosmetics, Food, Medical Devices, and Sanitary Products Industry.
WE ARE BS Regulatory Affairs
An consultancy company specialized in regulatory affairs. We have extensive training
and experience in the industry and know its needs internally. We provide advice to manufacturers, importers,
distributors, located inside or outside the country, on the regulatory aspects involving their products.
Our mission is to provide our clients with the tranquility of delegating the regulatory aspects of
their company, complying with current regulations while achieving their business objectives.
The ultimate goal is to be the leading consulting company for the Pharmaceutical, Cosmetic,
Food, and Medical Products Industry.
Our Services
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Chat with UsComprehensive management: imported, national, biological registrations, and maintenance. Reinscriptions. Modifications. Transfer
Preparation of Product Master Records (RMP).
Product Identification and Traceability.
Preparation of Historical Records.
Management of Complaints, Claims, and Technovigilance.
Appointment of Technical Directors.
Appointment of Representatives.
Technical Translations. Official and Unofficial.
Database Management.
Comprehensive management: imported, national, biological, and maintenance records. Reinscriptions. Modifications. Transfer.
Preparation of technical dossier for registration (development, quality control, stability, formulation, bioequivalence). Preparation of CTD format dossier for registrations abroad.
Identification and Traceability of products.
Import and Export.
Product Identification and Traceability.
Technical Verification of the First Batch.
Pharmacovigilance - Preparation of Risk Analysis, IPAs.
Appointment of Technical Directors.
Appointment of Representatives.
Preparation of Quarterly Reports for Controlled Substances, Preparation of Quarterly RENPRE Reports, and Preparation of Quarterly Reports for Restricted Substances.
Database Management.
Registration in the National Registry of Establishments - R.N.E.
Comprehensive management: registration and maintenance. Reinscriptions. Modifications. Transfer.
Import and Export..
Management of Complaints and Claims..
Appointment of Technical Directors.
Appointment of Representatives.
Technical Translations. Official and Unofficial.
Database Management.
Inscription of packaging and materials in contact with food.
Comprehensive management: imported and national registrations and maintenance. Reinscriptions. Modifications. Transfer.
Import and Export.
Management of Complaints and Claims.
Appointment of Technical Directors.
Appointment of Representatives.
Technical Translations. Official and Unofficial.
Database Management.
Registration of Sanitary Disinfectant Products risk I and II.
Registro de productos venta profesional e institucinal o(ANMAT-SENASA).
Import and Export.
Management of Complaints and Claims.
Appointment of Technical Directors.
Appointment of Representatives..
Technical Translations. Official and Unofficial.
Database Management.
Registrations
We have registrations for the following services:
Medical Specialties
Medical Products and Diagnostic Reagents
Dietary Supplements
Personal Hygiene, Cosmetics, and Perfumes Products
Authorizations
- Licenses for Manufacturer, Importer, and Exporter of Medical Products Establishments.
- Structure Modifications for Establishments.
- Licenses for Pharmacies, Distributors, and Logistics Operators. Re-enrollment. Comprehensive Maintenance.
- Registration of Establishment for Controlled Substances.
- Registration of Establishment for Restricted Substances (Disp. ANMAT 7771/15).
- Registration of Laboratories as Manufacturers and/or Packers of Personal Hygiene, Cosmetics, and Perfumes Products in the country.
- Registration of Laboratories as Importers of Personal Hygiene, Cosmetics, and Perfumes Products in the country.
- National Registry of Establishments - R.N.E.
- Licenses for Manufacturers, Importers, and Exporters Establishments before Health Authorities.
- We have an authorized importing company to represent your products locally.
Structure Modifications and Category Changes.
Assistance in case of Inspection (Accompaniment).
Registration of Distributors.
RENPRE Registration Certificate.
Quality
We provide the best quality with the following points:
Preparation of Good Practices Manual
Standard Operating Procedures (SOPs) according to current regulations.
Site Master File
Training
- Comprehensive Management for Beginner DT: Drugstore, Medical Products Distributor, Medical Products Importer, Food DT, and Cosmetics DT.
- Comprehensive Management of Controlled Substances.
- Market Withdrawal Management.
Bioequivalence-Bioexemption.
Management of Special Waste.
Registration and Maintenance of Medical Products.
Registration and Maintenance of Medical Devices.
Integral
- Technical Direction Practice.
Management before health authorities
Evaluation of regulatory context
Certifications
Official and Non-official Translations
What our clients say:
Working with this team has been an incredible experience. They understand our needs and deliver exceptional results. I highly recommend their services.
Robert Fox
Founder of Lorem CompanyWe've seen significant improvements in our business since partnering with this team. Their dedication and expertise are unparalleled. I definitely recommend them!
Annette Black
CEO of Ipsum CompanyThe team is incredibly talented and always exceeds our expectations. Their creative approach and professionalism are impressive. We couldn't be happier with the results!
Jerome Bell
Founder of the AgencyCustomer service is exceptional. They're always willing to help and find quick solutions. Working with them has been a very positive experience for our business.
