Strategic Regulatory Affairs, Pharmacovigilance, and Quality management across product lifecycle.
®
GLOBAL
REGULATORY
AFFAIRS
Trusted by Life Sciences companies as their experienced Regulatory Affairs partner, providing expert solutions for marketing authorization processes, regulatory intelligence, and lifecycle management across Peru, Latin America, and the Caribbean.
SCHEDULE A MEETING
18 +
Countries
Served
25 +
Global
Companies
LATAM
Regional
Experience
15+
Years
Experience
PRACTICE
AREAS
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Pharmaceuticals
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Biotech
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Biosimilars
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Medical Device
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Dietary suplements
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Cosmetics
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Food
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:
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Initial registrations
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Renewals
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CMC variations
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Lifecycle Management
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Deficiency letter response
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Labeling
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Regulatory intelligence
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Translations, etc.
GRA can handle the entire regulatory activity of your portfolio.
A regulatory project manager will be assigned to work closely with you.
We have successfully delivered regulatory projects across Latin America, including DIGEMID, ARCSA, ISP, ANMAT, INVIMA, and Caribbean regulatory authorities.
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 provides your organization with actionable regulatory intelligence and strategic insights across Latin America and the Caribbean, with extensive experience supporting projects before DIGEMID (Peru), INVIMA (Colombia), ANMAT (Argentina), ISP (Chile), ARCSA (Ecuador), and regulatory authorities throughout the Caribbean.
By mapping the regulatory landscape and identifying key stakeholders, GRA enables informed decision-making and proactive risk management. We work closely with your team to deliver strategic, evidence-based recommendations that minimize regulatory risks, accelerate market access, ensure regulatory compliance, and maximize business success across the region.
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:
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Good Manufacturing Practices
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Good Laboratory Practices
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Good Wharehousing Practices
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Good Distribution Practices
PHARMACOVIGILANCE OUTSOURCING
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
About_US
Global Regulatory Affairs (GRA) is a high-impact international consulting firm specializing in Global Regulatory Affairs for Pharma & the Life Sciences industry.
Founded in Peru in 2014, we support pharmaceutical, biotech, medical device, food, and cosmetic companies successfully obtain and maintain Marketing Authorizations in Perú (DIGEMID) and across LATAM & Central America (ARCSA, ISP, ANMAT, INVIMA).
We operate as a strategic regulatory partner, enabling companies to accelerate market access, reduce regulatory risk, and scale efficiently across emerging markets.
Our approach combines deep regional expertise with global regulatory standards, positioning GRA as a trusted partner for companies expanding into emerging markets.
OUR MISION
To provide strategic regulatory solutions that facilitate the registration and compliance of health products.
OUR APPROACH
We combine local expertise with international regulatory standards to deliver tailored solutions, reduce timelines and minimize regulatory risks.
OUR COMMITMENT
We work as your regulatory partner, offering expert advice, hands-on support and transparent communication at every stage of the process.
25+
Clients
Worlwode
18+
Countires
Served
15+
Years
Experience
100 +
Regulatory
Projects
completed
Global Reach, Local Expertise
Peru, Ecuador, Chile, Brazil, Colombia, Bolivia, Argentina, Mexico, Central America, USA, Canada, Spain, Germany, Italy, India, China, Japan, South Korea, Tunisia and more.
WHY_GRA?
We understand the complexities of regulatory environments in LATAM, (DIGEMID, INVIMA, ARCSA, ISP, ANVISA) and provide efficient, reliable and high-quality solutions to ensure your success.
END-TO-END SUPPORT
From regulatory strategy and dossier preparation to post-approval maintenance and variations.
EFFICIENCY & RESULTS
We help you avoid delays and rejections, optimizing timelines and resources.
EXPERT TEAM
Senior regulatory professionals with extensive experience in Perú & LATAM
CLIENT-CENTERED
We build long-term partnerships based on trust, transparency and measurable results.
"We are the partner of choice for patient-resoruce focused companies and strive to support them in their effort to commercialize products and innovative solutions that help patients around the world lead better, healthier lives".
CODE OF CONDUCT AND BUSINESS ETHICS
Contact
Perú (Hub - LATAM)
Address
SkyTower Business Center
Av. Javier Prado Oeste 757. Off. 1004
Zipcode: 15076
Lima-Perú
Email: info@gra.com.pe
Tel: +51 902 733 083
For any general inquiries, please fill in the following contact form:
