Who Is ADRES, and What Services Do We Offer?
ADRES is a specialized consultancy providing Quality Assurance (QA), Regulatory Affairs (RA), and Chemistry, Manufacturing, and Controls (CMC) support for pharmaceutical and medical device companies.
We partner with organizations at various clinical phases—helping them navigate regulatory pathways, implement robust quality systems, and bring safe, effective products to market.
Which Industries and Companies Do We Serve?
We primarily support biopharma, biotechnology, cell and gene therapies, and medical device companies, including startups, scale-ups, and established organizations.
Our cross-functional expertise allows us to deliver strategic QA, RA, and CMC solutions tailored to the unique challenges of each sector, from early-stage clinical development to post-market compliance.
Why Is Quality Assurance (QA) Critical for Life Science Startups?
Early-stage life science companies often face resource constraints and tight timelines. Robust QA not only ensures compliance with FDA, EMA, ISO, and other regulations, but also mitigates costly setbacks and enhances credibility with investors.
ADRES helps startups embed quality principles early, creating a strong foundation for scalable growth.
How Does ADRES Approach Regulatory Affairs (RA) Compliance?
Our RA approach involves end-to-end support—from regulatory strategy and submission preparation to post-approval maintenance. We monitor evolving guidelines (e.g., FDA, EMA, MDR/IVDR) and collaborate with internal teams to develop clear, compliant documentation.
This ensures smoother approval pathways and expedited time to market.
What Is Chemistry, Manufacturing, and Controls (CMC), and Why Is It Important?
CMC covers the development, characterization, manufacturing, testing, and control of drugs or biologics. Ensuring robust CMC strategies is vital for product quality, safety, and regulatory acceptance.
ADRES guides companies through GMP compliance, process validation, and tech transfer, ensuring a stable supply chain and consistent product performance.
How Does ADRES Differentiate Itself from Other Consultancies?
We offer a multidisciplinary perspective spanning QA, RA, and CMC under one roof, allowing our clients to streamline their development and compliance efforts. We work globally to ensure that our clients’ plans and activities align with all relevant regulatory bodies, minimizing the need for multiple consultants.
Backed by hands-on industry experience and up-to-date regulatory insights, creative and out of the box thinking, we provide an integrated framework that fosters a seamless transition from development through commercialization.
At What Stage Should Companies Engage ADRES for Consulting Services?
We recommend partnering with ADRES at the very beginning of the development process. By helping you choose the most suitable indication and target market, we ensure that all planned activities are strategically aligned and optimized to achieve critical milestones. Early involvement also helps minimize risks, streamline approval processes, and reduce unexpected challenges down the road.
How Can Our Consultancy Support Your Long-Term Compliance Strategy?
Beyond immediate projects, we partner with clients to develop ongoing compliance frameworks, conduct internal audits, and manage regulatory updates. This proactive approach helps maintain alignment with current standards, reduces post-market complications, and ensures continuous improvement across your organization’s operations.
Do We Have Global Regulatory Expertise?
Yes. Our team stays informed on global regulatory requirements, including those of the FDA (U.S.), EMA (Europe), and other international authorities. Whether you plan to launch in North America, Europe, or Asia, ADRES can guide you through the varying approval processes and post-approval obligations.
How Can You Get Started with ADRES?
If you’re ready to strengthen your QA, RA, or CMC capabilities, simply reach out via our Contact Form or schedule a consultation.
We’ll discuss your project’s needs, outline a customized plan, and work closely with your team to ensure a smooth path toward regulatory success and product launch.
Why Do Biotech Companies Need Regulatory Consulting Services?
Biotech firms often develop cutting-edge therapies or novel drug modalities, facing unique regulatory hurdles and rapid scientific advancements.
Regulatory consulting ensures that product development is aligned with FDA, EMA, and global guidelines from the outset. This not only streamlines approvals but also reduces the risk of costly delays and enables biotech companies to focus on innovation rather than navigating complex compliance requirements alone.
How Can I Choose the Right Regulatory Consulting Firm for My Biotech Company?
Look for a partner with industry-specific expertise, a track record of successful regulatory submissions, and knowledge of emerging technologies.
Ask about global capabilities, their approach to communication, and whether they offer integrated services (e.g., QA, RA, CMC) that can reduce the need to juggle multiple vendors. At ADRES, we pride ourselves on our hands-on approach, ensuring that each biotech client receives customized solutions aligned with their project goals.
What Are the Steps to Submit a Regulatory Application for a New Drug?
While the exact process varies by region, a typical new drug application involves:
1. Preclinical and Clinical Data Compilation: Gathering robust safety, efficacy, and pharmacology data.
2. CMC Documentation: Demonstrating manufacturing consistency, purity, and stability.
3. Regulatory Strategy and Dossier Preparation: Assembling technical documents in the required format (e.g., eCTD).
4. Filing the Application: Submitting to authorities such as FDA (NDA, BLA, PMA) or EMA (MAA) Notified bodies (Technical File).
5. Regulatory Review and Response: Addressing questions and clarifications from the agency.
ADRES provides strategic guidance and hands-on support at each stage, helping biotech companies meet submission requirements efficiently.
What Is Included in QA (Quality Assurance) Consulting for Biotech Companies?
QA consulting typically covers:
• Quality Management Systems (QMS): Designing and implementing SOPs, audits, and metrics.
• Regulatory Compliance: Aligning processes with GxP guidelines (GMP, GLP, GCP) and local/international regulations.
• Risk Assessment: Identifying, documenting, and mitigating product and process risks.
• Training and Continuous Improvement: Equipping teams with up-to-date best practices and driving a culture of quality.
Through ADRES’s QA services, biotech companies can maintain consistent product quality, uphold patient safety, and ensure seamless readiness for regulatory inspections.
What Is including in CMC (Chemistry, Manufacturing, and Controls), and Why Is It Important?
CMC consulting for biotech companies involves defining and optimizing the chemistry, manufacturing processes, and control strategies for biological products (e.g., monoclonal antibodies, cell therapies).
Strong CMC ensures consistent product quality, scalability, and compliance with GMP. ADRES helps you:
• Develop Robust Manufacturing Protocols
• Validate Processes and Facilities
• Prepare CMC Documentation for regulatory submissions
• Establish Ongoing Quality Control to address potential challenges as products move from clinical to commercial stages
By investing in CMC consulting, biotech companies can de-risk their development pipelines and establish trust with regulators, paving the way for successful market entry.