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Regulatory Affairs Services

Bringing a medical product to market is incredibly complex. But, at Apotech, we have the skills and knowledge required to ensure complete regulatory compliance during both its clinical development and the entire project life cycle. 

Trusted expertise from drug development to life cycle management

Helping you navigate through clinical trials and authority approvals

At Apotech, we specialise in guiding pharmaceutical and biotech products through the complex regulatory world involved, from Clinical Development through to Marketing Authorisation Life Cycle Management

With expertise spanning both EU and US regulations, our services align with the rigorous standards outlined by the FDA, EMA and many other key international regulatory bodies, and are designed to ensure a smooth, compliant path when bringing medical products to market. 

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Trusted by top-tier teams worldwide

Drug Development

Our drug and clinical development services are designed to navigate the complexities of clinical trials with precision and expertise. We offer a wide variety of technical tasks and support, including:

Trial design and protocol development. 

  • We can craft detailed study protocols focused on your trial objectives, methodologies, statistical considerations and ethical compliance.

Regulatory submission and liaison expertise.

  • Our team can work with you to prepare a variety of regulatory documents, such as Investigational New Drug (IND) applications and Clinical Trial Applications (CTAs), while liaising with regulatory bodies like the FDA, EMA and local authorities to secure approvals.

Data management and biostatistics.

  • We use cutting-edge data management systems to guarantee data integrity, while also applying sophisticated biostatistical methods when performing in-depth data analyses. 

Clinical trial monitoring and management.

  • From ensuring GCP compliance to managing study budgets and timelines, our team can support you during clinical trials in several ways.

Safety reporting and pharmacovigilance excellence. 

  • We can help you establish robust systems to not only ensure safety data is submitted to regulatory authorities on time but to also help maintain a vigilant approach to pharmacovigilance practices.

Medical Writing

Apotech has a comprehensive range of services related to regulatory writing and support for both clinical and nonclinical development. These services cover various aspects of regulatory submissions, documentation, and compliance across different regulatory authorities. A breakdown of our key services:

Regulatory Writing Support:

  • Tailoring support based on submission type and regulatory authority requirements

Nonclinical & Clinical Documentation:

  • Clinical Study Report (CSR)
  • eCTD Modules 2.4, 2.5, 2.6, and 2.7
  • eCTD Modules 4 and 5

Clinical Trial Support:

  • Clinical Trial Protocol (CTP)
  • Investigator Brochure (IB) 
  • Efficacy and safety summaries
  • Patient/safety narrative writing

Integrated Summaries:

  • Support on Integrated Summaries (ISS, ISE, and ISI)

Scientific Writing Services:

  • Publication, abstract, poster, brochure, presentation preparation.
  • Literature searches and reviews

Toxicological Risk Assessment:

  • Assessment of impurities, extractables & leachables, excipients, and industrial chemicals.
  • Exposure Level (OEL) calculations

FDA Submissions

Embark on your clinical journey with confidence through our specialised services tailored for the FDA. From crafting robust Investigational New Drug (IND) applications to navigating the intricacies of New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA), we offer a spectrum of services to streamline your path through the FDA. Our expertise extends to Biologics License Applications (BLA) and strategic FDA meeting preparations, ensuring a proactive and efficient approach.

Investigational New Drug (IND) Applications:

  • Preparation and submission of comprehensive IND packages, including nonclinical and clinical data, to facilitate FDA approval for clinical trials.
  • Expertise in crafting pre-IND meeting briefing packages, ensuring efficient communication with regulatory authorities.

New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA):

  • In-depth support for NDA and ANDA submissions, covering chemistry, manufacturing, and controls (CMC), nonclinical, and clinical modules.
  • Assistance in addressing FDA Complete Response Letters (CRL) and preparing robust response packages.

Biologics License Applications (BLA):

  • Strategic guidance on BLA preparation for biopharmaceutical products, emphasising comparability studies and post-approval changes.
  • Expertise in navigating the FDA's accelerated approval pathways.

FDA Meeting Preparation:

  • Conducting pre-submission meetings and coordinating interactions with the FDA.
  • Crafting meeting packages, including briefing documents, to optimise communication and address regulatory concerns effectively.

EU Regulatory Submissions

Unlock the potential of the European market with our dedicated support for Marketing Authorisation Applications (MAA), Clinical Trial Applications (CTA), and Orphan Drug Designation Applications. Whether pursuing centralised or decentralised approvals, our team is well-versed in the nuances of the European Medicines Agency (EMA) processes. Post-approval, we provide vigilant compliance support, managing variations and renewal applications to uphold marketing authorisation.

Marketing Authorisation Applications (MAA):

  • End-to-end support for MAA submissions, covering quality, safety, and efficacy data.
  • Assistance in preparation for Oral Explanations and CHMP meetings for centralised submissions.

Clinical Trial Applications (CTA):

  • Streamlining CTA submissions for both individual EU member states and the centralised procedure.
  • Comprehensive support for addressing regulatory queries and protocol amendments during the trial.

Orphan Drug Designation Applications:

  • Expert assistance in preparing orphan drug designation applications, including clinical trial design optimisation.
  • Support in maintaining orphan drug status post-approval.

Post-Marketing Regulatory Compliance:

  • Vigilant post-approval support, managing variations, periodic safety update reports (PSURs), and other post-marketing requirements.
  • Timely submission of renewal applications and compliance checks to ensure continuous marketing authorisation.

Consulting and Strategy

Regulatory Pathway Optimisation:

  • Tailored strategies for expedited regulatory pathways, including Fast Track, Breakthrough, and Accelerated Approval programs.
  • Optimisation of clinical trial designs to support regulatory objectives.

Regulatory Training and Workshops:

  • Customised training programs for regulatory teams, focusing on evolving regulatory requirements and best practices.
  • Interactive workshops covering specific regulatory challenges and case studies.

Risk Management and Mitigation:

  • Comprehensive risk assessments, including identification of potential regulatory hurdles.
  • Development of risk mitigation plans, incorporating contingency strategies for regulatory success.

Life Cycle Management 

From the initial application to any post-approval modifications, we have a thorough understanding of regulatory life cycle management and offer a wide range of services to ensure continuous regulatory compliance. These include: 

Regulatory Strategy Development:

  • Tailored strategies for successful regulatory submissions and approvals.
  • Expertise in navigating the dynamic regulatory landscape for both pharmaceuticals and biotech products.

Regulatory Intelligence and Compliance:

  • Continuous monitoring of global regulatory changes impacting the life cycle of pharmaceutical and biotech products.
  • Comprehensive compliance services to ensure adherence to evolving regulations.

Product Variations Management:

  • Major Variations:
  • Expert guidance and submission support for major changes in product composition, manufacturing processes, or indications.
  • Minor Variations:
  • Efficient handling of minor variations such as labelling updates, administrative changes, and packaging modifications.
  • Separate and Grouping Variations:
  • Assistance in managing separate and grouping variations to optimise regulatory processes.

Product Renewal:

  • Renewal Planning and Submission:
  • Development of strategic plans for product renewal, ensuring continuous market authorisation.
  • Timely preparation and submission of renewal applications to regulatory authorities.

Market Authorisation Transfer:

  • Inter-Regional Transfers:
  • Expertise in managing market authorisation transfers between different regulatory regions.
  • Intra-Regional Transfers:
  • Assistance in transfers within a specific regulatory region, ensuring compliance with local regulations.

Labelling and Product Information Management:

  • Ensuring compliance with global labelling regulations throughout the product life cycle.
  • Strategic management of product information to meet evolving regulatory standards.
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Services designed to deliver complete compliance

We understand how crucial regulatory compliance is in the pharma and biotech industries, not only to gaining approval for clinical trials but to also eventually marketing your medicines and products. 

That’s why we are always here to lend our expertise. Whether you need specific regulatory support during a product’s clinical development journey or advice on how to handle post-approval modifications, we can tailor our services to help in any way you need.


We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have.

Here are some of the questions we get asked most often.

Our team has extensive experience in Advanced Therapy Medicinal Product (ATMP) clinical development and is well-versed in how to deliver compliance throughout the development process. Get in touch with us for further information. 

Featured case studies

Global in-country regulatory support 

510(k) Submission Introduction Top 3 Global CRO Our client is one of the largest CROs globally, with operations present in every economy. Their services range from Clinical Development, Medical Affairs, and Commercial Delivery. Apotech continues to partner with them on a 3-year FSP contract. Apotech’s Consultants  Our 18 strong Consulting team includes a mixture of…

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