Pharma Regulatory Consultants in India, Pharma Consultancy in Delhi

India Regulatory Services

The journey from the birth of a concept to the approval of a product is a difficult one especially when faced with tough regulations. CliniExperts offers a cost effective method to make this journey smooth and easy. Our knowledge of the laws and regulations pertaining to the development, testing, approval, manufacturing, commercialization and post-marking surveillance of a product provides you a good vantage point. Our focus is to acquire speedy approvals to enable clients achieve their objective of a timely and successful product launch.

We Offer Regulatory Solutions to :

Drug

New Drugs, SND, FDC, API, Bulk Drugs, Test Licenses, BE NOC, etc. for importers, manufacturers and traders

Food

Regulatory support for FSSAI. Import assistance, Licensing and registration, FSSAI compliance, Product Approval

Cosmetic

Manufacturing license, Cosmetic registration and approval, Labeling assistance, Testing etc.

Medical Device

Medical device registration, Import license, Clarification from CDSCO, Performance evaluation, MDAC meeting support, etc.

Diagnostic Kit

Notified and Non-Notified Diagnostic kits, Registration, Import license, Test license, Performance evaluation, MDAC meeting support, etc.

Biologicals

Registration of biologicals, Import license, Test license, Export NOC, Regulatory support for CLAA, LVP, Serums, NOC for Vaccines, etc.

Pesticide and Insecticide

Registration of Pesticides, Herbicides, Insecticides, Technical, Formulation, Import assistance on RTT, etc.

CRO

GCT approval, Safety reporting, Test license, CTRI registration, Ethics committee registration, etc.

Narcotics Regulatory Affairs

Manufacturing license, Narcotic and Psychotropic Drugs, Export NOC/Certificate, Import NOC/Certificate, NOC for Import/Export of Precursor chemicals

Legal Metrology

Registration of Importer, Registration of Manufacturer, Importer and Packer (Packaging and Warehouses), License as a Manufacturer, License as a Dealer, License as a Repairer, Model Approval, Stamping and Verification

Wireless Planning and Coordination

DoT, ETA, Non-Network License, Import License, DPL, NDPL, Demonstration License, Network License, ISP License, Experimental License

Phytopharmaceutical Drug

Application to Conduct Clinical Trial, Import of Phytopharmaceutical Drugs, Manufacture of Phytopharmaceutical Drugs

Our Additional Services

Authorized Agent / Registration Holder

We hold valid Drug Wholesale License and can act as an authorized agent in India on your behalf. This will enable you in rapidly completing the process of registration and entry into Indian market. Timing is the key to a successful product launch anywhere in the world.

Biological Sample- ICMR

NOC for Import and Export, DNA, Saliva, Blood, etc.

Legalization

MEA, Embassies like Nigeria, Columbia, Myanmar, Dominican Republic, Thailand, Philippines, Jordan, UAE, Singapore, Algeria, Chile, Ethiopia, Taiwan, Vietnam, Russia, etc.

We assist our clients for regulatory matters
in concern with the following authorities:

We assist our clients for regulatory matters in concern with the following authorities

Zonal Cdsco — CDSCO/State FDA/ Zonal CDSCO

Entry To India Market

We offer strategic planning services during product registration in addition to finding distributors and acting as an authorized agent in India. With our knowledge of the Indian regulatory scenario and its intricacies, we can help you achieve your goal without any hindrances. Our experienced team is well aware of all the formal and informal processes to be fulfilled on the path to complete approval and launch in the Indian market. Our hand in glove approach ensures that at no point you find yourself battling with any process by yourself.

Clinical Trial Registration Consultants India

Regulatory Intelligence and Strategy

We at CliniExperts will be with you throughout your journey. Our strategies are planned and executed by professionals who will aid you throughout the process starting from dossier preparation, product test support, registration of product and even post registration changes

Authorized Agent / Registration Holder Support

Global manufacturers without representation in India can appoint an authorized agent with a valid drug wholesale license to register their products. We at CliniExperts can act as an authorized agent on your behalf to speed up the approvals and registration processes which accelerates your regulatory process leading to a quicker market entry.

Distributor Identification

The professional relationships we have forged over the years will help you find distributors in India with absolute ease.

Distribution Point

We act as a stock point for international companies providing end-to-end services for import, clearance and warehousing of the products using strong networking with logistic companies ensuring timely availability to distributors in India.

DRUG

FOOD

COSMETIC

MEDICAL DEVICE

DIAGNOSTIC KIT

BIOLOGICALS

PESTICIDE AND INSECTICIDE

CRO

GLOBAL REGULATORY Services

Entering into the vast realm of pharmaceutical products in international markets of EU, USA and other emerging ones like African subcontinent, requiresa comprehensive understanding of complicated regulatory requirements. At CliniExperts, we ease the process of seeking swift approval for your products by defining country specific regulatory strategies right at the nascent stage of product development, eliminating potential roadblocks and ironing out any kinks en-route to a successful product launch.

Strategy Planning

The CliniExperts team puts together a time tested regulatory strategy, customized to your specific requirement that identifies and mitigates potential challenges in order to obtain approval for EU, USA and Emerging Markets. The team defines Clinical (CT/BA-BE, Published information, RLD/Comparator suggestion), Non-clinical (pre-clinical/Tox data) and Technical requirements (API and Drug Product specification & advise, Stability data, evaluation and proposed shelf life,) and helps in developing a quality product dossier. Furthermore, a country specific product strategy is developed. All these efforts are with one sole intent, 100% client satisfaction.

Pre-Registration

Data Generation and Data Review w.r.t Drug Substance and Drug Product DMF
- Development & Preparation of R&D documents
- Dissolution Comparative Studies Designing and Data Report
- AM development and Validation as per ICH Q2A, Q2B
- BA/BE studies
- Reference Listed Drug (RLD)/Innovator Product/Comparator
Regulatory & Quality Compliance Services & Expert Reports
- GMP Audits/Site Due Diligence- API Site, FP Sites, Manufacturing Sites
- Gap analysis on the Existing documents/data/dossier and conversion to country specific/ACTD to CTD and vice versa
- Guidance & assistance on generation of data for successful submission of the Dossier to Country MOH/Health authorities.

Registration

DMF (CTD format) Preparation, Review and Submission
Dossier Writing and Review
Dossier Registration: Submission to various regulatory agencies worldwide
Handling of query Responses

Post-Approval Changes

CliniExperts provides post-approval services which include carrying out product re-registration is well ahead of time. Renewal of Site GNP is also carried out according to schedule. Services also include renewal of BE center GCP certification and submission of Annual Product Review Submission to the concerned health authority. The complete life cycle of the product is planned and executed by CliniExperts.

Regulatory Submissions

DMF, GENERICS, IND/CTA/NDA, Pre-IND meetings / Scientific Advice meetings, Pre-NDA meetings

Quality and Compliances

API, Formulations, Co-ordination with Regulatory Agencies & final response to CAPA; GLP & GCP at Toxicity Centre(s) and CRO respectively.

Markets

Regulated Markets
U.S.A, Europe, Canada, South Africa, Australia, NZ, etc

Semi Regulated Markets
ASEAN, CIS, Middle East, Africa, LATAM (Brazil, Mexico, Peru, Venezuela, Costa Rica etc.), GCC, etc.

TESTIMONIALS

Our clients are the biggest testament to our success and caliber. Ranging from Manufactures to Importers to CROs, our client database is as vast as it is diverse.

Sathya Managing Director – South Asia, Galderma India Pvt. Ltd.

We have been associated with CliniExperts for the last 5 years. During this tenure, we have found them very professional in their approach, good understanding of the subject with strong ethical and compliance standards. They adhere to the mutually decided timelines and keep us updated on the project on a regular basis. We thank them for all their support and wish them all the best.

Boddu Ganesh Dy. Manager-Regulatory Dept, Eisai India, Vizag, AP.

Thank you very much for the superb service solidified on our various regulatory projects. Your knowledge, expertise and skills are the key factors for the successful delivery.

CliniExperts got us the approvals for the projects which are very critical. That was fabulous job.

We appreciate the efforts taken in delivering the assignments without much delay. Status Update, Documentation and Support rendered while processing the applications were remarkable.

Sunitha Conybio Healthcare (India) Pvt. Ltd

Thankyou very much for the wonderful service rendered on our various regulatory projects. We appreciate the efforts taken in delivering the assignments without much delay. Status Update, Documentation and Support rendered while processing the applications were phenomenal. Your knowledge, expertise and skills are the key factors for the successful delivery.

One product registration was really critical. Our product was lying in the port and we were in need of a cosmetic registration urgently to clear the stock. In minimum span of time we got the Registration done and cleared the stock from the port without much demurrages. That was a commendable job.

Yash Shrivastav Intercorp Biotech Limited

We have had a great experience with CliniExperts. Their expertise in handling the Indian regulatory environment makes them the perfect partner. All our requirements were taken care of swiftly and on time.

R.L Goyal C.E.O (Superchem Nutri Formulations)

CliniExperts team is efficient, understanding, cooperative with Superchem and FBO’s to attend each requirement and query relating to product approval system as well as regulatory authorities.
They are great help to us. Our best wishes for CliniExperts.

Pawan Shukla Regulatory Affair Manager (Valentine Agro Pvt. Ltd.)

I just want to say Thanks! To the entire CliniExperts team for providing the outstanding support to help us to understand the various Food Regulation & to reply the various FSSAI queries letters for Product approval applications on time. You people are simply great, very alert; very approachable; I’m very fond of your way of working with FSSAI & your scientific justification & literature to resolve the various FSSAI queries professionally. In addition to being very friendly. CliniExperts are simply the Best Regulatory partner anyone can have for various regulatory supports. Once again Thank you to all CliniExperts team for having resolved my FSSAI tricky problems and for your wonderful support.