How Biotech firms can ensure Regulatory Compliance: An Expert Guide


Table of Contents

Introduction. 3

What is the concept of a Regulatory Processes?. 3

What you need to do and know to stay at the top of your business. 4

What Is the Importance of Regulatory Compliance?. 5

How do organizations need to ensure regulatory compliance?. 6

The Role of EMA Regulatory Compliance in the Product Life Cycle. 7

Throughout the product lifecycle, there is a high level of Regulatory Compliance. 7

Inspections are used to ensure that everything is in working order in order to meet regulatory compliances  8


Regulatory compliance refers to the set of organizational processes, policies, and procedures that help biotech companies comply with the laws, rules, regulations, requirements, and guidelines set by the legislatures in the countries where they operate. Every organization must abide by the biotech compliance rules and regulations of the countries in which it operates. Specific requirements may differ depending on the industry and type of business. As businesses develop in size and scope, they are subjected to an increasing number of rules that govern how they conduct business.

Regulatory compliance is the organizational practice of ensuring that business is done in conformity with applicable rules and laws. Altogether, the regulations are in place for a reason: they secure your company, its employees, and its consumers.

Because the regulatory biotech compliance process is so important, your company must take a comprehensive, deliberate approach to develop an effective regulatory compliance program in 2022.

What is the concept of Regulatory Processes?

A regulatory process is a government-enacted regulation or legislation that imposes a legal duty on a company and increases its biotech compliance costs. The regulatory requirement may apply to all companies doing business in a particular state or country, to organizations in the biotech industry. As a matter of fact, that the regulatory process has become highly politicized as governments sought to protect national industries battered by the economic crisis due to pandemics. Many regulators in the United States are responsible for overseeing the conduct of private corporations in their specific industries. Among them are the following:

The drug-approval process is controlled by the government regulatory agency inside the United States Department of Health and Human Services, which is entrusted with assessing new medications and medical devices before firms may market them. A pharmaceutical business seeking FDA clearance to commercialize a novel prescription drug must go through a five-step procedure that includes creation, non-clinical study, clinical study, FDA approval, and FDA post-market safety monitoring. On or before 2022, a pharmaceutical firm seeking FDA approval to commercialize a new prescription drug must complete the mentioned five-step process.

What you need to do and know to stay at the top of your business

Conforming to a rule, such as a specification, policy, standard, or regulation, is what biotech compliance entails in general. Regulatory compliance is the objective that companies strive towards in their efforts to ensure that they are aware of and follow all applicable laws, policies, and regulations. Organizations are increasingly using unified and harmonized sets of compliance controls as a result of the growing number of rules and the requirement for operational transparency. This strategy is used to guarantee that all relevant governance standards are completed without duplicating effort and activity from resources.

For completing reporting obligations, some businesses hold compliance data—all data belonging to or related to the company or contained in the legislation that may be utilized for the purpose of implementing or confirming compliance in a separate repository. Compliance software is increasingly being used to help businesses manage their compliance data more efficiently. Calculations, data transfers, and audit trails may be stored at this location.

Biotech compliance differs not just by industry, but also frequently by region. A country’s financial, scientific, and pharmaceutical regulatory regimes, for example, could be comparable in one country but have very different characteristics in another. These parallels and contrasts are frequently the results of “reactions to shifting aims and needs in various nations, sectors, and policy situations.”

Unquestionably the EMA countries’ financial sectors are highly regulated. The “observance of external (international and national) rules and regulations, as well as internal norms and procedures, to maintain the integrity of the business” is a popular definition of biotech compliance with its management, and employees with the goal of preventing and controlling risks and potential damage resulting from compliance and integrity risks.”

Industry in the United Kingdom is heavily regulated, with part of it originating from European Union legislation. The list of regulatory bodies in the United Kingdom includes the Financial Conduct Authority (FCA), the Health Care Quality Commission, the Medicines and Health Products Regulatory Agency (MHRA), and others. After January 1, 2021, all medical devices, including in vitro diagnostic medical devices (IVDs), are necessary to be registered with the MHRA. The MHRA protects public health in the United Kingdom by licensing and enforcing pharmaceutical medicines for human use, as well as enforcing medical device rules.  The MHRA also controls clinical trials for pharmaceuticals and medical devices.

Only UK producers or UK Competent Persons can apply for MHRA registration:

  1. In the UK a responsible person must have a location of the business in the United Kingdom
  2. It is necessary to provide a product list that includes the items to be registered as well as the relevant Global Medical Device Nomenclature (GMDN) code
  3. A copy of the CE certificate, if relevant, should be given
  4. Manufacturers that are not based in the UK but must designate a UK Responsible Person do not need to update the labeling of their products sold in the UK

The role of FCA is to focus its efforts on authorization and new business, including applications for authorization from businesses using a temporary permit system. The FCA seems ready to tackle more difficult cases, even if it may not always win those cases.

This new approach is already visible in the interaction of enterprises with FCA and will continue in 2022.

The International Organization for Standardization (ISO) standard is one of the primary international standards for how businesses handle regulatory biotech compliance, reminding us that compliance and risk should work together as “colleagues” with certain nuances to allow for their differences, having a shared framework. The ISO also creates worldwide standards to assist enterprises in meeting regulatory compliance with their best practices for security management and assurance.

ICH achieves harmonization by collaborating with regulatory and industry professionals to produce guidelines and technical standards for the development, authorization, and safety monitoring of pharmaceuticals. The guidelines are adopted by ICH regulatory members, who are expected to follow them.

What Is the Importance of Regulatory Compliance?

It’s important to know that the failure to satisfy regulatory compliance standards can result in significant fines or penalties, depending on the nature of the infraction. That is something that the company must constantly keep in mind while managing risk. Aside from the penalty, there is always the risk of losing one’s reputation. Who wants to do business with a firm that has made headlines for failing to follow applicable regulations?

Consequently, government rules set the direction that helps companies thrive, and noncompliance is often associated with many types of company failure.

Poor regulatory compliance can also have the following consequences:

  1. Suspension or exclusion from government contract bidding
  2. Defeat to the company’s reputation as a reliable business partner
  3. Individuals who willfully violate the law may be subject to individual sanctions or imprisonment.
  4. Business activities are disrupted as a result of inquiries or legal procedures.

It is always essential to comply with the appropriate rules regulating your line of business.

How do organizations need to ensure regulatory compliance?

Regulatory compliance is ensured through a variety of actions, including:

  • Working to gain a better understanding of their industry regulatory framework as well as the jurisdictions in which they operate.
  • As new regulatory compliance requirements emerge, work to comprehend them.
  • To guarantee compliance with the applicable rules, policies, processes, procedures, and working methods must be established and adopted.
  • Establishing policies and procedures to detect and prevent non-compliance within the company.
  • Using software technologies to automate compliance operations and centralize compliance management.

On the other hand, the level of biotech compliance and regulations is determined by each company depending on their risk management system. Certain legislation, such as the new European privacy regulation General Data Protection Regulation (GDPR), requires security in the processing of personal information. But what exactly does that imply? Even the regulatory law specifies that security must be ensured in accordance with the acceptable risk. As a result, any company that handles personal information must do its own risk assessment. Appropriate security measures must be applied depending on the risk involved and the business’s risk tolerance.

The Role of EMA Regulatory Biotech Compliance in the Product Life Cycle

Most organizations involved in the development, marketing, production, and distribution of medicines must adhere to all relevant EU legislation and pharmaceutical guidelines. The European Medicines Agency (EMA) is in full control of harmonizing these standards across the EU. As well as it is coordinates inspections to verify biotech compliance.

Throughout the product lifecycle, there is a high level of Regulatory Compliance

Research and development Marketing authorization application Post-authorization
Good laboratory practice (GLP)
Good clinical practice (GCP)
Good manufacturing practice (GMP)
Pharmacovigilance inspections
Sampling and testing
Good distribution practice (GDP)
Quality defects and recalls
Falsified medicines: reporting obligations


The EMA is the primary contact for submitting a suspected quality concern with any centrally authorized product, and it also organizes the investigation, assessment, and follow-up in such circumstances. On request from the Committee for Medicinal Products for Human Use (CHMP) or the Committee for Medicinal Products for Veterinary Use (CVMP), EMA coordinates inspections for human and veterinary medicines authorized under the centralized procedure or in the context of a referral (CVMP).

In addition, EMA has a sampling and testing procedure in place to ensure the quality of centrally authorized medicines that are put on the market and that they meet their approved criteria.

The EMA also plays an important role in coordinating and harmonizing actions across the EU, such as:

  • creation and harmonization of EU standards
  • development of EU instructions on inspections and related processes
  • development of recommendations through working groups of inspectors
  • coordination assistance in the interpretation of regulatory requirements

All of these critical points must be at the top of the list of EMA biotech firms in 2022.

Inspections are used to ensure that everything is in working order in order to meet regulatory compliances

Authorities in the EU investigate sites inside and outside the EU that are engaged in the development, production, and distribution of human or veterinary pharmaceuticals on a regular basis to ensure biotech compliance with EU market standards. These inspections ensure that clinical-trial subjects’ rights, safety, and well-being are respected, as well as the reliability and integrity of data used to support the approval of medications once they’re on the market, they’ll be judged on their quality, safety, and effectiveness.

An inspection can be ‘for cause,’ meaning it is triggered by a finding of possible non-compliance with relevant standards, or it can be ‘routine,’ meaning it is carried out as part of a surveillance program. Inspections are carried out for both approved medicines and medicines under evaluation in the EU.

The types of inspection are as follows:

In order to succeed in the biotech industry in 2022, you’ll need to master all of these organizational skills along with regulatory compliance. Agencies collaborate to maintain regulatory compliance, allowing us to safely enjoy the benefits of biotechnology. The guidelines also involve the development and use of biotechnology products and services. Regulations govern the manufacture, marketing, including the use of biotech materials.

Looking to hire a regulatory compliance consultant? Browse through some highly rated experts here.


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