GLOBAL
REGULATORY
AFFAIRS

®

Regulatory Services :

Pharmaceuticals | Medical devices | Biotech |Biosimilars |

Dietary supplements | Cosmetics | Food products|

Regulatory Outsourcing

Markets :

LATAM ( PE, CL, EC, CO, AR ) | Central America Region

PRACTICE
AREAS

SUBMISSION MANAGMENT

Marketing Authorization (MA)

Global Regulatory Affairs team works eamlessly with your team and stakeholders on regulatory strategies, submission planning and tracking to ensure applications are delivered to a high standard meeting all eCTD compliance requirements and according to schedule.

Our service covers all aspects of product lifecycle:

Initial registrations
Renewals
CMC variations
Lifecycle Management
Deficiency letter response
Labeling
Regulatory intelligence
Translations, etc.

GRA can handle the entire regulatory activity of your portfolio.

A regulatory project manager will be assigned to work closely with you.

REGULATORY OUTSOURCING

Today, large, medium and small companies in the pharmaceutical sector choose to outsource the area of Regulatory Affairs / Technical Management with the aim of focusing their resources on the capitalization of commercial strategies generating much more dynamic and efficient organizations.

Global Regulatory Affairs® has developed a work platform where you will be able to know in real time all the activities and/or processes that are being executed, thus generating specific monitoring of your company's resources.

Your company will be charged for only the hours spent completing each activity during the contracted work period. We have an expert team ready to support your regulatory operations.

We invite you to learn more about our process, which will generate efficiency in the management of time and resources in the area of Regulatory Affairs.

REGULATORY INTELLIGENCE

GRA team bring to your organisation relevant information regading trends, competitors, a well as the bureaucracies and regulatory forces that drive key developments in your sector.

Once the regulatory landscape and stakeholders are mapped, GRA team supports your company with and strategic and informed inputs to minimize regulatory risks and increase the business’s success.

REGULATORY HOSTING & COMPANY OPENING

Do you want to start operations in Perú, LATAM and Central América Region?, GRA assists manufacturers in business & office opening in Perú by offering the service of legal & technical representation while your products are getting registered with us.

Speed up the execuction of your projects.

DUE - DILIGENCE

If the decision is to look for acquiring in-license products or companies; or to out-license products, a high quality decision-making needs to be led by a detailed and accurate assessment of the available information & data.

Our highly experienced team supports your company in this critical stage by carrying out a detailed analysis of the regulatory & GxP status to ensure a solid due diligence process.

Global Regulatory Affairs reports the findings to highlight areas of concern, and assessing the risks and benefits of the list of products or company you plan to acquire.

GxP CERTIFICATIONS

GMP / GLP / GWP / GDP

If you have a regulatory audit coming up, make sure you are ready by having a pre-audit by one of our experienced consultants. We can help you develop a GMP / GLP / GWP / GDP compliance roadmap to guide you on your way.

Global Regulatory Affairs’ audit experts can work to evaluate systems at your pharmaceutical, biotechnology, or medical device organization or at your vendor sites to determine if the systems in place are sufficient to meet your needs and the current regulatory standards.

As an extension of your Auditing team, we’re able to conduct audits on your behalf, using our roadmap or your established audit program, whichever works best for your needs.

Global Regulatory Affairs audit preparation covers:

Good Manufacturing Practices
Good Laboratory Practices
Good Wharehousing Practices
Good Distribution Practices

PHARMACOVIGILANCE

Global Regulatory Affairs offers Human Pharmacovigilance, including the provision of Responsible Person for Pharmacovigilance (RPPV) with the necessary tools, experience and expertise to support Sponsors, Marketing Authorization Holders and Applicants.

In accordance with the Peruvian regulation on good pharmacovigilance practices, Marketing Authorization Holders (MAHs) are required to perform regular risk-based audits of their PV system, and can any time be inspected by the drug regulatory authority (DIGEMID).

Keep your business in compliance and avoid hazards/penalties that might put at risk your operation in Perú

Practice Areas

ABOUT US

About Us

Global Regulatory Affairs (GRA) is an international consultant firm that began activities in Peru on 2014 with the aim to support multinational and local pharmaceutical companies to obtain Marketing Authorizations in Peru, LATAM and Central America Region. Nowadays, pharmaceutical, biological, medical devices, cosmetic, hygiene and food companies are supported by GRA to focus on their core business trougout an expert advice, guidance, training & recruitment services in Regulatory Affairs.

The regulatory activity represents a series of challenges that must be resolved quickly in order to avoid delays in getting products to consumers; for that reason, GRA is comprised of senior regulatory professionals with extensive experience in Peru and Latin American sanitary legislation so that we can help your organization to handle the entire regulatory process, from the initial submission to post approval activities, saving time and resources by avoiding re-submission due to rejections.

Clients Worldwide

Global Regulatory Affairs reached +25 clients worldwide located in Perú, Ecuador, Chile, Brasil, Colombia, Bolivia, Argentina, EEUU, Mexico, Canada, Guatemala. Spain, Germany, Italy, India, Tunisia, South Korea, China, Japon.

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