Are You Looking For Regulatory Affairs Consultant?
At Medwisdom Lifescience, we provide consultancy services for overall regulatory submission and approval along with due diligence, connect with us to know more.
- Fast and Reliable Services
- Expert Advice and Consultation
- More Than 50 Happy Clients
Regulatory Affairs Consulting
At Medwisdom Lifescience, we provide regulatory affairs consultation combined with regulatory strategy to simplify your path of product approval. Our team which includes former FDA manager, NDA application reviewer, and industry experts are dedicated in providing simple, reliable, and effective regulatory solutions towards encountered hurdles of regulatory compliance and overcome challenges. We aim to deliver transparent and efficient regulatory consultation, ensuring your goal meets your expectations on time.
We are specialized in providing regulatory affairs consultation that would help you mitigate potential delays and challenges. Our services includes preparation of CTD, ACTD, and eCTD dossier for product registration with regulatory compliance standard globally. We offer services from brand pharmaceutical products to generic drugs, preparing and submitting FDA required regulatory documents such as Investigational New Drug Application (IND) for requesting approval of clinical trials on human, New Drug Application (NDA) for innovative drug, Abbreviated New Drug Application (ANDA) for generic drugs, DMF (Type I, II, III, IV) preparation and many more.
Our Expertise Across Therapeutic Areas
Indian Regulations Global Understanding
Our Regulatory Affairs Consultancy Services In India
Pharmaceutical
- Regulatory Strategy
- CTD Dossier Preparation For Drug Molecules
- Technology Transfer From Small Scale To Production Unit
- Regulatory Submission For Obtaining Registration
- Medical and Scientific Writing Expertise
- Clinical Study Reports and Observational Study Reports
Medical Device
- Wholesale License for Medical Device (MD-42)
- Test License for All Classes of Medical Device
- Grant of Manufacturing License (Class A,B,C,& D)
- Import License For Medical Device
- Sugam Portal Registration (CDSCO)
- National Single Window System (NSWS) Portal
- Preparation of Drug Master File (DMF) For Medical Device
- Development of Risk Management Plan For Medical Device
Cosmetics
- Regulatory Affairs Consulting for Grant of Import License for Cosmetics Under Form COS 1
- Complete Support for Grant of Cosmetic Manufacturing License Under Form COS-8
- Label and Artwork Guidance for Avoiding Issues
- Post-marketing Surveillance for Cosmetic Products
What Our Clients Think About Us
Frequently Asked Questions
What Is Regulatory Affairs Consulting?
Regulatory Affairs Consulting involves the guidance and support of industrial experts to his client, in various sectors including pharmaceutical, cosmetics, medical device, and nutraceuticals. Regulatory affairs consultants are those, who have the experience in products registration by solving queries of regulatory authorities.
What Industries Does Medwisdom Lifescience Serves?
We offer consultancy services for different industries focusing mainly on:
- Pharmaceuticals
- Medical Device
- Cosmetics
- Nutraceuticals
- Herbal
- Food Industry
What Are The Regulatory Affairs Services Does Medwisdom Lifescience Offers
We offers diverse range of regulatory services including:
- CTD, ACTD, and eCTD Dossier Preparation
- Regulatory Submission
- Medical Device Registration
- Grant of License For Cosmetics Products
- Labelling and Artwork Review
- Complete Product Lifecycle Management
Which Countries Do Medwisdom Lifescience Covers?
We are global regulatory affairs consultant, providing regulatory support to our clients in markets such as US, Europe, CIS, African, ASEAN, and LATAM.