The Certified Regulatory Affairs Professional/Manager (CRAP)™/(CRAM)™ certification program is a globally relevant and professionally structured qualification designed for individuals involved in regulatory affairs, compliance management, and governance across regulated industries. In today’s highly regulated global environment, organizations must navigate complex and evolving regulatory requirements to ensure product safety, quality, compliance, and market access. Effective regulatory affairs professionals play a critical role in minimizing regulatory risk, supporting business strategy, and maintaining trust with regulators and stakeholders.

Regulatory affairs extends far beyond document submission and compliance checks. It involves understanding regulatory frameworks, interpreting guidelines, developing regulatory strategies, ensuring quality and compliance across the product lifecycle, managing post-market obligations, and communicating effectively with regulatory authorities and internal stakeholders. This program equips participants with structured regulatory knowledge, strategic planning capabilities, and compliance management skills applicable across domestic and international regulatory environments. Emphasis is placed on proactive regulatory strategy, risk-based decision-making, and alignment between regulatory requirements and business objectives.

Graduates of the CRAP™/CRAM™ program will be capable of managing regulatory responsibilities with confidence, accuracy, and strategic insight in both professional and managerial roles.

Certification Program Objectives:

Upon completing the Certified Regulatory Affairs Professional/Manager (CRAP)™/(CRAM)™ program, participants will be able to:

• Understand Regulatory Fundamentals and Guidelines – Develop a strong foundation in regulatory concepts, frameworks, standards, and guidance documents.
• Navigate Global Regulatory Requirements – Interpret international regulatory systems and harmonization efforts across regions and markets.
• Manage Quality Assurance and Compliance – Apply quality systems, compliance controls, and audit readiness practices.
• Develop Regulatory Strategy and Planning – Create proactive regulatory strategies aligned with product development and business goals.
• Manage Post-Market Surveillance and Risk – Monitor product performance, manage safety reporting, and mitigate regulatory risks post-approval.
• Communicate Effectively with Regulatory Stakeholders – Engage regulators, internal teams, and external partners professionally and transparently.

Certification Requirements:

To apply for certification from The American Institute of Business and Management (AIBM) and its allied institutions, candidates must meet the following criteria:

• A Bachelor’s degree from a recognized institution

And/or

• 0–4.9 years of relevant experience for Professional level (CRAP)™, or 5+ years of relevant experience for Manager level (CRAM)™

Note: Applicants who do not hold a Bachelor’s degree but possess exceptional professional experience and hold significant positions within their organizations in a relevant field may also be considered for certification on a case-by-case basis, subject to the approval of the AIBM evaluation committee.

Certifying Examination:

• To be certified as CRAP™/CRAM™, student should take up a 1.5 hours online exam conducted by AIBM.
• The qualifying exam would consist of 50 multiple choice questions, testing core certification modules.
• Professionals with relevant experience and other qualifying criteria may be exempted from the examination.

Certification Modules:

• Module 1: Regulatory Fundamentals and Guidelines
• Module 2: Global Regulatory Requirements and Harmonization
• Module 3: Quality Assurance and Compliance Management
• Module 4: Regulatory Strategy and Planning
• Module 5: Post-Market Surveillance and Risk Management
• Module 6: Regulatory Communication and Stakeholder Engagement

*  The Certification Title and its modules are regularly reviewed, updated and may change in alignment with evolving industry needs and regulatory standards.

Who Should Do This Certification:

The Certified Regulatory Affairs Professional/Manager (CRAP)™/(CRAM)™ certification is ideal for professionals and graduates seeking to build structured expertise in regulatory compliance and governance. It is particularly valuable for:

• Regulatory Affairs Professionals responsible for submissions, approvals, and compliance management.
• Quality Assurance and Quality Management Professionals working in regulated environments.
• Pharmaceutical, Biotechnology, Medical Device, and Healthcare Professionals involved in regulatory processes.
• Manufacturing and Operations Professionals supporting compliance and audit readiness.
• Risk and Compliance Professionals managing regulatory and product-related risks.
• Consultants and Advisors supporting regulatory strategy and compliance initiatives.
• Graduates and Career Switchers aspiring to enter regulatory affairs or compliance-focused roles.

Key Benefits of CRAP / CRAM Certification:

• Professional Recognition – Establishes credibility as a qualified regulatory affairs and compliance professional.
• Career Advancement – Supports progression into roles such as Regulatory Affairs Manager, Compliance Manager, or Regulatory Strategy Lead.
• Strong Regulatory Knowledge Base – Enhances understanding of domestic and international regulatory frameworks.
• Risk-Aware Compliance Management – Strengthens ability to identify, manage, and mitigate regulatory risks.
• Strategic Regulatory Thinking – Improves alignment between regulatory requirements and business objectives.
• Effective Regulatory Communication – Builds confidence in engaging regulators and stakeholders professionally.
• Cross-Industry Applicability – Relevant across pharmaceuticals, medical devices, biotechnology, healthcare, chemicals, food, and other regulated industries globally.

The CRAP™/CRAM™ certification empowers professionals to manage regulatory responsibilities with clarity, discipline, and strategic foresight. By mastering regulatory fundamentals, global requirements, quality systems, post-market obligations, and stakeholder communication, certified individuals are well-positioned to support compliant operations, successful market access, and sustainable organizational growth.