RAF Consulting

REGULATORY-AFFAIRS SERVICES

Consulting services:

Regulatory strategy and intelligence
Consulting from the start-up in Mexico or specific consulting on your products
Borderline products classification
Regulatory consulting during the different phases of product-development
Facility (warehouse, manufacturing facilities) requirements to be able to hold registrations and import, distribute, and market your Healthcare Products in Mexico
Strategy and regulatory intelligence: selection of best registration process, according to your needs and product characteristics.
Product concept definition
Rx to OTC switches
Regulatory auditing
Publicity campaigns revision (companies, drugs, wines and liquor, health services, etc.)

Registration of healthcare products (drugs and medical devices):

Dossier review and organization, with or without submission to Cofepris (Federal Commission for Protection Against Sanitary Risks- Mexican Ministry of Health)
Dossier auditing (for fusions or products licensing)
Dossier integration for Center- and South-America

We have great experience in registering all kinds of healthcare products (drugs and medical devices) and other related products, such as dietary supplements, cosmetics, health services and food. We can do notifications or registration of products through any path:

Authorized third parties in sanitary verification (Private companies approved by Cofepris to review and pre-approve dossier; afterwards, the dossier is submitted to Cofepris though a fast track)
Equivalence procedures with other countries’ Ministries of Health.
Traditional path directly to Cofepris

Medicines - drugs (pharmaceutical products)

Medical devices

Establishments (GMP compliance)

Publicity

Registration holder for medical devices

Pharmacovigilance services

We provide a flexible and comprehensive service in all related to compliance of the norm (NOM-220-SSA1-2015) – Installation and operation of pharmacovigilance – or the current one.

Our promise is to adapt to your company’s particular needs, policies, and requirements at a competitive cost. We are focused on a high level of regulatory compliance with high quality standards.

We have a professional team highly qualified and with solid experience in the field, and a support M.D. for whenever is necessary.

We can become your Pharmacovigilance Department, including discharge of the Pharmacovigilance Unit before CEMAR (Cofepris area which regulates pharmacovigilance), naming of a pharmacovigilance responsible
Development and/ or update of Standarized operation procedures (SOP) manual
Operating of the Pharmacovigilance Unit, including reception, investigation, maintenance of databases and reports on suspicion of adverse reactions to medications (SARM) before CEMAR
Calendar-scheduled of pharmacovigilance activities per hired registration, as well as generation of periodic safety reports, safety in Mexico reports, technical sheets, and pharmacovigilance reports on time for your registration renovation
Qualification of your personnel in reception and identification of SARM’s

Generation and approval of pharmacovigilance protocol or program for any kind of drug product.

Development of risk-management plans (RMP)
Development or update of SOPs manual
Periodic Safety report (PSUR)
Safety reports in Mexico
Technical sheets
Pharmacovigilance reports for registration renewal
Local and international bibliographic revision
Development and implementation of active or intensive pharmacovigilance programs
Operation and implementation of RMP’s
Pharmacovigilance in clinical studies
Classification, management, investigation and report on notifications, submission to Cofepris and follow-up

Technovigilance

By being registration holders, RAFconsulting® is an approved technovigilance unit by Cofepris. We can take care of everything for you, including your technovigilance unit and responsible.

We provide a flexible service to adapt to your company’s particular needs, policies, and requirements at a competitive cost. We have a high level of regulatory compliance in all our services. We have a professional team highly qualified and with solid experience in the field, and a support M.D. for whenever necessary.

We can become your Technovigilance Department, including discharge of the Technovigilance Unit before CEMAR (Cofepris area which regulates pharmacovigilance), naming of a technovigilance responsible
Development and/ or update of Standarized Operating Procedures (SOP)
Operating of the Technovigilance Unit, including reception, investigation, maintenance of databases and notifications on suspicion of adverse reactions to medical devices before CEMAR
Calendar-scheduled of technovigilance activities per hired registration, as well as technovigilance reports on time for your registration renewal.
Qualification of your personnel in reception and identification of notifications.

Technovigilance inform
SOP manual
Qualification in technovigilance
Local and international bibliographic revision

Call Center

Call center and assignation of an exclusive 01800, to answer your calls, complaints, and notifications.

It is not the same having a call center than having a commuter or specialized number in reception of notifications.

Having a call center gives you complete control and access to any made call in case it is needed. Some of the services we provide are:

Call center and assignation of an exclusive 01800 to your company
Exclusive agents, qualified and trained specific for your company’s needs
Recording of 100% of the calls
Identification of calls on-hold, missed calls, incoming and outcoming calls, service statistics and KPI’s
Development of scripts, templated and call manuals, where you can control exactly what the agent says, capture specific information, and escalate the call in particular cases
Database creation and backup with top technology

Other services we can provide are:

Customer service center
Reception and management of quality complaints
Information on products to patients or health professionals
Telephonic campaigns, mailings, etc.

We have qualified, specialized, healthcare-related personnel to attend the call center. We have top technology for call-management and report system:

100% equipped stations
Digital main line/ IP voice
Carrier and internet redundancy
Call Center-specialized platform
Recording of 100% of calls
Progressive and predictive markers
WFM/ MIS
Data mining/ clusters/ CRM
Key performance indicator
Comprehensive registry system

Services