Comprehensive Regulatory Services Tailored for Life Sciences Companies

Freyr Solutions is a global Regulatory solutions and services company, supporting Life Sciences companies in their entire Regulatory value chain.​

Freyr Solutions offers services across various industries, including Pharmaceuticals, Medical Devices, Consumer Healthcare, Cosmetics, Food and Food Supplements, and Chemicals

Freyr Solutions provides a wide range of services, including Regulatory Affairs, Pharmacovigilance, Clinical Research, Quality Assurance, Compliance, and Regulatory Intelligence

Yes, Freyr Solutions operates globally, offering services to clients across the Americas, Europe, Asia-Pacific, and the Middle East.​

Freyr Solutions has its headquarters in Hyderabad, India, with additional offices in the USA, UK, Germany, Malaysia, and other locations worldwide.

Freyr Solutions' mission is to provide end-to-end Regulatory solutions that ensure compliance, accelerate market entry, and enhance the quality of healthcare products globally.​

Yes, Freyr Solutions offers tailored solutions to meet the unique Regulatory requirements of startups and small to medium-sized enterprises (SMEs).​

Freyr Solutions ensures quality through a team of experienced professionals, adherence to global Regulatory standards, and implementation of robust quality management systems.​

Clients can contact Freyr Solutions through their official website's contact form, by email at , or by phone at their regional office numbers.

Yes, Freyr Solutions offers career opportunities across various domains. Interested candidates can explore current openings on their careers page.​

Regulatory Affairs Services

Freyr Solutions assists in the preparation, submission, and management of Regulatory filings, ensuring compliance with the specific requirements of each country's health authorities.​

Freyr Solutions provides Regulatory strategy development, dossier preparation, submission management, and post-approval maintenance for pharmaceutical products

Yes, Freyr Solutions offers services for medical device registration, including Regulatory strategy, technical documentation preparation, and liaison with Regulatory authorities.​

Freyr Solutions supports cosmetics companies with product registration, ingredient assessment, labeling compliance, and safety assessments to meet global Regulatory standards.

Freyr Solutions offers services such as product classification, formulation review, labeling compliance, and submission support for food and dietary supplements.​

Yes, Freyr Solutions assists in compiling and submitting Drug Master Files (DMFs) to Regulatory agencies, ensuring compliance with regional requirements.​

Freyr Solutions provides end-to-end support for clinical trial applications, including protocol development, submission preparation, and Regulatory liaison.

Freyr Solutions offers services for post-approval changes, including variation submissions, labeling updates, and lifecycle management of approved products

Yes, Freyr Solutions provides Regulatory intelligence services, offering insights into evolving Regulatory landscapes and helping clients stay compliant.​

Freyr Solutions ensures compliance by staying updated with global Regulatory changes, implementing best practices, and maintaining transparent communication with clients.​

Pharmacovigilance Services

Freyr Solutions offers comprehensive pharmacovigilance services, including adverse event reporting, signal detection, risk management, and periodic safety update reports (PSURs).

Yes, Freyr Solutions provides end-to-end Individual Case Safety Report (ICSR) management, from data collection to submission to health authorities.​

Freyr Solutions assists in developing risk management plans, identifying potential risks, implementing mitigation strategies, and monitoring their effectiveness.​

Freyr Solutions employs advanced methodologies and tools to detect, assess, and manage signals, ensuring timely identification of potential safety issues.​

Yes, Freyr Solutions offers literature monitoring services to identify relevant safety information from scientific publications and Regulatory sources.

Freyr Solutions provides Qualified Person for Pharmacovigilance (QPPV) services, ensuring compliance with EU pharmacovigilance requirements.

Freyr Solutions ensures compliance by adhering to global pharmacovigilance regulations, implementing robust quality systems, and conducting regular audits.​

Yes, Freyr Solutions offers pharmacovigilance training programs tailored to client needs, covering Regulatory requirements, processes, and best practices.​

Freyr Solutions supports clients during Regulatory inspections by providing preparation assistance, conducting mock audits, and offering post-inspection support.​

Freyr Solutions utilizes validated safety databases and advanced IT solutions to manage pharmacovigilance data securely and efficiently.​

Clinical Research Services

Freyr Solutions offers clinical research services, including study design, site selection, monitoring, data management, and Regulatory compliance.​

Yes, Freyr Solutions provides end-to-end clinical trial management, ensuring compliance with Good Clinical Practice (GCP) and Regulatory requirements.​

Freyr Solutions assists in developing clinical trial protocols, ensuring scientific validity, ethical compliance, and alignment with Regulatory expectations.​

Freyr Solutions ensures data quality through rigorous monitoring, standardized procedures, data validation, and adherence to industry best practices.​

Yes, Freyr Solutions offers biostatistics services, including study design consultation, statistical analysis, and interpretation of clinical trial data.​

Freyr Solutions ensures compliance by adhering to global Regulatory requirements, implementing robust quality management systems, and conducting regular training.​

Yes, Freyr Solutions provides medical writing services, including the preparation of clinical study reports, investigator brochures, and scientific publications.​

Freyr Solutions supports site selection by evaluating potential sites based on experience, patient population, facilities, and past performance.​

Freyr Solutions manages patient recruitment through strategic planning, site engagement, and implementation of effective recruitment strategies.​

Yes, Freyr Solutions offers clinical trial auditing services to ensure compliance with protocols, GCP, and Regulatory requirements.​

Quality Assurance and Compliance

Freyr Solutions offers quality assurance services, including audits, gap analyses, SOP development, and compliance training.

Yes, Freyr Solutions provides Good Manufacturing Practice (GMP) compliance services, including audits, remediation plans, and training.

Top Indian Books for Mastering Regulatory Affairs and Life Sciences – Recommended for Freyr Solutions Professionals

"Regulatory Affairs in Pharmaceuticals" by Dr. Ramesh Kumar – Pharma Med Press
Covers drug approval processes, global regulations (India, US, EU), and eCTD submissions. Contains scenario-based MCQs and documentation checklists.

"Essentials of Drug Regulatory Affairs" by C. V. S. Subrahmanyam – Vallabh Prakashan
Focuses on Indian and international drug laws, product registration, and licensing. Includes case studies and regulatory form samples.

"Textbook of Pharmacovigilance" by Dr. Prema K – Himalaya Publishing House
Offers in-depth insights into adverse event reporting, signal detection, and global PV practices. Includes real-world safety scenarios.

"Handbook of Clinical Research" by Dr. B. N. Singh – Nirali Prakashan
Ideal for beginners in clinical trials, ethics, monitoring, and data handling. Contains GCP-based questions and SOP drafting tips.

"Pharmaceutical Regulatory Affairs" by Dr. K. G. Bothara – Career Publications
Discusses regulations of pharmaceuticals and cosmetics. Includes comparative frameworks and regulatory workflow charts.

"Drug Development and Regulatory Affairs" by Dr. Avinash Kadam – Techmax Publications
Covers clinical development, quality documentation, and dossier preparation. Contains regulatory timelines and FAQs.

"Global Regulatory Strategy" by Dr. Meena Sharma – CBS Publishers
A practical guide to managing product lifecycles across multiple regions. Features regulatory project management exercises.

"Introduction to Cosmetics Regulatory Affairs" by Dr. Sunita Reddy – S. Chand Publishing
Covers Indian BIS guidelines, labeling laws, and global compliance norms. Useful for QA and RA professionals in cosmetics.

"Medical Device Regulations in India" by R. K. Jain – Dhanpat Rai Publications
Detailed breakdown of CDSCO approvals, classifications, and QMS for devices. Includes step-by-step approval procedures.

"Regulatory Compliance for Nutraceuticals" by S. Rajasekaran – Oxford University Press
Focuses on FSSAI guidelines, label claims, and submission requirements. Good resource for food supplement companies.

"Clinical Trials: Process and Ethics" by Dr. Asha Pillai – Paras Medical Publishers
Covers trial phases, subject rights, and Indian ethics committees. Includes review templates and mock protocols.

"Quality Management Systems for Pharma" by Dr. Ashok Vaidya – Pharma Knowledge Series
Offers insights into ISO, WHO-GMP, and ICH guidelines. Great for professionals overseeing audits and QMS.

"Indian Drug Regulatory Landscape" by V. S. Rao – Cengage Learning
Overview of D&C Act, New Drugs Rules, and CDSCO processes. Includes revision questions and timelines.

"Pharmaceutical Documentation and Submissions" by Dr. Alok Mehta – Pragati Books
Detailed approach to DMFs, ASMFs, CTDs. Contains templates and sample formats for filings.

"Good Pharmacovigilance Practices" by Dr. R. Swaminathan – Jaypee Brothers
Covers ICSR management, PBRERs, and PV audits. Suitable for pharmacovigilance teams in CROs and pharma companies.

"Food Safety and Regulatory Compliance" by S. Lalitha – New Age International
Useful for food technologists and RA professionals. Covers FSSAI, Codex, and international guidelines.

"Biological Product Regulations" by Dr. Neeta Sharma – PharmaNext
Discusses biosimilars, biologics approvals, and comparability studies. Offers summaries of Indian and global laws.

"Regulatory Affairs for Herbal Drugs" by P. R. Chandrasekhar – Himalaya Publishing
Focuses on AYUSH norms, global acceptance of herbal products, and claims validation. Includes herbal dossier structures.

"CMC and Regulatory Writing" by Dr. Jayanti Nair – Lotus Press
Covers technical writing for CMC documents, quality modules, and summary writing skills. Includes sample sections for Module 3.

"Labeling Compliance and Regulatory Writing" by Anita Joshi – PharmaVision Books
Practical guide for drug and device labeling, serialization, and SmPC creation. Helpful for label reviewers and documentation teams.

Freyr Solutions: Redefining Regulatory Excellence in Life Sciences

Freyr Solutions stands as a powerhouse in the world of regulatory affairs, offering end-to-end services tailored to the dynamic needs of the life sciences industry. From pharmaceuticals to medical devices, nutraceuticals to cosmetics, Freyr is trusted for its deep domain knowledge and global expertise.

With ever-changing regulatory landscapes, life sciences companies face significant challenges to ensure compliance, achieve timely approvals, and enter global markets without hurdles. Freyr Solutions bridges these gaps with strategic consulting, regulatory intelligence, and operational support. Their services span the entire product lifecycle — from development to post-market surveillance — ensuring clients meet every requirement set by global health authorities like USFDA, EMA, CDSCO, MHRA, and more.

One of Freyr's biggest strengths lies in its robust team of regulatory experts. With experience across more than 120 countries, the company is well-equipped to navigate region-specific complexities. Whether it's preparing a Common Technical Document (CTD), responding to regulatory queries, or managing eCTD submissions, Freyr ensures accuracy and compliance at every step.

Pharmacovigilance is another area where Freyr Solutions leads with distinction. They offer complete safety monitoring services, including Individual Case Safety Report (ICSR) processing, signal detection, risk management, and safety data analysis. Using best-in-class tools and processes, Freyr helps clients ensure patient safety while maintaining global regulatory alignment.

Freyr’s clinical research services further amplify their holistic approach. They support clinical trial applications, regulatory submissions, and ethics committee interactions. By aligning with ICH-GCP standards, Freyr ensures that all clinical operations meet international benchmarks, enhancing the credibility of submitted data.

In today’s digital-driven environment, Freyr also excels in regulatory publishing, labeling compliance, and digital health support. Their team handles labeling updates, SmPCs, PILs, and country-specific packaging requirements with precision. In parallel, their tech-driven publishing tools help clients manage submissions seamlessly.

Startups and established enterprises alike benefit from Freyr’s scalable models. Their flexible service delivery – ranging from full-time equivalents (FTEs) to project-based support – ensures that businesses only pay for what they need. This customer-centric model has made Freyr a partner of choice for companies aiming for faster go-to-market strategies.

With global operations and 24/7 client support, Freyr Solutions stands out as not just a service provider, but a strategic partner in regulatory transformation. Their dedication to quality, innovation, and compliance continues to make a meaningful impact in the life sciences ecosystem.

Whether you're launching a new molecule or expanding into new markets, Freyr Solutions offers the regulatory clarity, speed, and confidence needed to succeed.