We understand healthcare company’s regulatory requirements and knowledge to bridge the gap between the challenges you face and gain the favourable outcome that you want. With a team of experienced RA/QA consultants working across the globe, we can assist budding startups to multinational enterprises, we have been there and know how to position each of our client’s success.
Our subject matter experts have been providing incomparable services for our clients. Our experts work from four continents and help minimise the regulatory burden, offering practical, usable advice and solutions that work for our clients and the regulators.
Our team of experts, ex-regulators, doctors, scientists, pharmacists, product specialists, and risk management specialists, will support you with the knowledge and security you need to address problems that occur in Regulatory clearance/approvals, Techno vigilance, Pharmacovigilance, Manufacturing, Distribution, and more.
Each customer is unique to us, we tailor services to our customer’s specific requirements. As compliance partners — whether it’s a certification experience from one source or perhaps just guidance on the regulatory path — we always put our efforts to accelerate innovation, promote the breakthrough of great ideas and communicate global regulatory intelligence to our clients fully meet their regulatory obligations and adopt them easily throughout their organisation with little disruption to their business.
We acknowledge that no two clients and no two days are the same in the fast-changing regulatory world. With the breadth of our experience, we help you evolve with it efficiently. Our services are flexible, and we will customize our services to meet the client’s needs.
We provide services for the following sectors:
- Medical Devices and In-Vitro Diagnostics
- Medicinal Products
- Cosmetic Products
- Insecticide Products
Our Range of services includes, but are not limited to :
- QMS Implementation
- Worldwide in-Country representations
- Product Risk Assessments
- Product Determination and Classification
- Labelling and Packaging Review
- Clinical Study planning, developing, submitting CTA, INDs etc to national and international EC approvals
- Clinical Evaluation Plan and Report writing
- Compilation and review of Technical Files and Design Dossiers
- Documentation, Preparation, and submission of the dossier
- Auditing — Internal QMS, Technical files, Design Dossier, & Suppliers.
- Pharmacovigilance & Techno vigilance
- Market Authorization Submissions
- Worldwide Product Registrations I Submissions
- Post Approval Changes on Product and Manufacturer sites etc
- Special Approval / Permissions / Wavier / No Objection Certificate (NOC)
- Import License and Registration Certificate
- Digital Health [SaMD (AI/ML)] Regulatory guidance and technical file Creation
- Digital Health [SaMD (AI/ML)] Data Analysis
- Wholesale Licensing/Registration Certificate (Form 42 or 20B & 21 B)
- Expertise in guidance on Global Cosmetics Regulation
- Creating and/or compiling Product Information File (PIF) and Pack (PIP)
- Certificate Expert Safety Assessor Sourcing
- Insecticide registration
- National Pharmaceutical Pricing Authority (NPPA) site registration and information to the authority
CONSULTANCY FOR CERTIFICATION SERVICES
Our range Of regulatory and quality services includes:
- ISO 13485 OMS-MD
- ISO 9001 (for Medical Devices) in
Combination with ISO 13485
- EC Cenification (EU 2017/745
Medical Device regulation
- UKCA Marking
- MDSAP Certification (Single Audit program)
- PMDA(Ord. 169)
- ISO 27001 Information Security
- ISO 14001 Environmental
- ISO 45001 Occupational Health
- 510(K) Clearance support service for test data advisory, and factory follow-ups
- PMA Submission
- Mock Audits prior to NB Certification Audits
More — Please contact RSIL representative:
THIRD-PARTY TESTING VIA APPROVED PARTNERS
Our services include:
- NABL and NABH lab testing
- EU/lnternational product safety.
Including testing to the IEC/EN 60601 and IEC/EN 61010 series and the CB scheme, testing requirements for over 52 countries worldwide
- US NRTL (UL Standards) and standards council of Canada
- EMC Testing (IEC/EN 60601-1-2 and CE marking)
- Approval for overlapping EC Directives: Machinery, PPE,
Pressure Equipment, NonAutomatic Weighing Equipment
- Wireless testing / Telemedical
- Restricted substance testing. Including testing to RoHS.
requirements for medical devices
- Penetration testing Of Software as Medical Devices (SaMD).
Others
OTHER SERVICES RELATED TO HEALTHCARE
Our services include:
- Biocompatibility evaluation and biological evaluation Of medical devices according to ISO 10993
- Audits — Supplier audits, Gap analysis audits, FDA cGMP audits
- Clinical Evaluations Reports
- Hygienic qualifications of Production facilities
- Microbiological tests of Products before and after Sterilizations
- Product Control for possible toxic residues from the sterilization process
- Training including QMS/auditing (ISO 9001. 13485. 14001: Internal auditing), global regulations (CE marking, FDA, JPAL), sterilization (radiation, ethylene oxide, steam); risk management (ISO 14971) and product safety and EMC (the IEC 60601 series)
- Other regulatory compliance solutions/consultancy for the United Kingdom, EMEA; USA; LATAM;
Australasia; APAC, and CIS countries.
Our Mission
To empower businesses by delivering transparent, reliable, and efficient regulatory consulting solutions that simplify compliance and promote sustainable growth.We aim to be the most trusted partner for companies seeking clarity and confidence in complex regulatory environments.
Our Vision
To become a leading regulatory consulting firm in India, recognized for our integrity, innovation, and excellence in helping businesses grow responsibly.We envision a business ecosystem where every organization — from startups to large enterprises — operates with complete compliance, confidence, and credibility.
Why Choose Us
At Rico Solutions India Pvt. Ltd., we believe that every growing business deserves clear, reliable, and result-driven regulatory support. Our team of experienced consultants understands the complexities of compliance and works with complete transparency to deliver practical, timely, and customized solutions. We don’t just help you meet regulatory requirements — we help you build a strong foundation for long-term success. With our deep industry knowledge, commitment to excellence, and client-first approach, we ensure your business operates confidently, stays compliant, and continues to grow without disruption.
Growing with our clients
